Transcatheter puncture needle system

ABSTRACT

A puncture needle can comprise a puncture tip configured to pierce tissue, and a distal portion comprising an anchor portion and a curved puncture portion. The curved puncture portion can comprise a first end associated with the puncture tip and a second end coupled to the anchor portion, where the anchor portion comprises a portion distal of the curved puncture portion. A puncture needle system can comprise the puncture needle and a delivery catheter comprising a lumen, the puncture needle extending through the lumen. The delivery catheter can have a side outlet opening on a distal portion of the delivery catheter configured to allow extension therethrough of at least a portion of the curved puncture portion, where the anchor portion extends through a portion of the lumen distal of the side outlet opening.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of PCT InternationalPatent Application Serial No. PCT/US2020/050623, filed Sep. 14, 2020 andentitled TRANSCATHETER PUNCTURE NEEDLE SYSTEM, which claims the prioritybased on U.S. Provisional Patent Application Ser. No. 62/902,747, filedSep. 19, 2019 and entitled TRANSCATHETER PUNCTURE NEEDLE SYSTEM, thecomplete disclosures of both of which are hereby incorporated byreference herein in their entireties.

BACKGROUND Field

This disclosure generally relates to the field of transcatheter punctureneedles used in the delivery of medical implant devices and/ortherapies.

Description of Related Art

Transcatheter delivery of a puncture needle to a target vessel, channel,chamber and/or organ can be performed in minimally invasive proceduresto form an opening at a target tissue site. The opening can be formedsuch that medical implant devices and/or therapies can be provided tothe target tissue site. For example, delivery of implant devices and/ortherapies to the heart can be performed for treatment of elevatedpressure in the left atrium.

SUMMARY

Described herein are devices, systems, and methods relating totranscatheter puncture needles. The puncture needles can be used inminimally invasive procedures for forming openings at target tissuesites, including on a left atrial wall within the heart.

In some implementations, a puncture needle can comprise a puncture tipconfigured to pierce tissue, and an elongate portion. The elongateportion can comprise a distal portion comprising a curved punctureportion having a first end associated with the puncture tip, andextending from the first end to a first bend having a first acute angleoriented distally; a first distal elongate portion, the first distalelongate portion meeting the curved puncture portion at the first bend,and the first distal elongate portion extending from the first bend to asecond bend having a second acute angle oriented proximally; and asecond distal elongate portion, the first distal elongate portion andthe second distal elongate portion meeting at the second bend, and thesecond distal elongate portion extending proximally from the secondbend. The second bend can be distal of the curved puncture portion.

In some embodiments, the first distal elongate portion, the seconddistal elongate portion and the curved puncture portion are in oneplane. In some embodiments, the elongate portion is a single wire.

In some embodiments, the first distal elongate portion comprises a firstdistal curved portion and the second distal elongate portion comprises asecond distal curved portion, the first distal curved portion and thesecond distal curved portion having a same orientation as the curvedpuncture portion. In some embodiments, a radius of curvature the curvedpuncture portion is smaller than that of each of the first distal curvedportion and the second distal curved portion.

In some implementations, a puncture needle can comprise a puncture tipconfigured to pierce tissue, and an elongate portion comprising a distalportion, the distal portion comprising a curved distal elongate portionand a curved puncture portion extending from the curved distal elongateportion to the puncture tip. The curved distal elongate portion and thecurved puncture portion can have a same orientation. A distal end of thecurved distal elongate portion can be distal of the curved punctureportion.

In some embodiments, a radius of curvature of the curved distal elongateportion is greater than that of the curved puncture portion.

In some implementations, a puncture needle can comprise a puncture tipconfigured to pierce tissue, and a distal portion. The distal portioncan comprise an anchor portion, and a curved puncture portion comprisinga first end associated with the puncture tip and a second end coupled tothe anchor portion. The anchor portion can comprise a portion distal ofthe curved puncture portion.

In some embodiments, the curved puncture portion is proximally oriented,and wherein the puncture tip points proximally. In some embodiments, thecurved puncture portion is distally oriented, and wherein the puncturetip points distally.

In some embodiments, the curved puncture portion comprises a segment ofa circle. In some embodiments, the curved puncture portion comprises asemi-circle.

In some embodiments, the distal portion comprises a lateralcross-section having a rectangular shape, the lateral cross-sectionbeing taken along a plane perpendicular to a longitudinal axis of thepuncture needle.

In some embodiments, the anchor portion is a curved anchor portion, thecurved anchor portion comprising the portion distal of the curvedpuncture portion, and a proximal portion coupled to the second end ofthe curved puncture portion. In some embodiments, the curved anchorportion and the curved puncture portion comprise a same orientation. Insome embodiments, a radius of curvature of the curved puncture portionis smaller than that of the curved anchor portion. In some embodiments,the curved anchor portion comprises a shape configured to conform to acurvature along a length of a coronary sinus.

In some embodiments, the anchor portion can comprise a first anchorportion comprising a first end and a second end, wherein the first endof the first anchor portion is coupled to the curved puncture portion;and a second anchor portion comprising a first end coupled to the secondend of the first anchor portion, and wherein the second anchor portionextends proximally from the first end of the second anchor portion. Thefirst anchor portion and the second anchor portion can meet at a bend,where the bend can be proximally oriented and the bend can be distal ofthe curved puncture portion. In some embodiments, the bend comprises anacute angle.

In some embodiments, the curved puncture portion, the first anchorportion, and the second anchor portion are in one plane. In someembodiments, the first anchor portion is a first curved anchor portionand the second anchor portion is a second curved anchor portion. In someembodiments, the curved puncture portion, the first curved anchorportion, and the second curved anchor portion comprise a sameorientation. In some embodiments, a radius of curvature of the curvedpuncture portion is smaller than that of each of the first curved anchorportion and the second curved anchor portion. In some embodiments, thefirst curved anchor portion and second curved anchor portion eachcomprise a shape configured to conform to a curvature along a length ofa coronary sinus.

In some embodiments, the first anchor portion and the second anchorportion are each linear portions. In some embodiments, the curvedpuncture portion is proximally oriented, wherein the curved punctureportion and the first end of the first anchor portion meet at a distallyoriented first bend, wherein the first anchor portion and the secondanchor portion meet at a proximally oriented second bend.

In some implementations, a puncture needle system can comprise apuncture needle and a delivery catheter. The puncture needle cancomprise a puncture tip and a distal portion. The distal portion cancomprise an anchor portion, and a curved puncture portion comprising afirst end associated with the puncture tip and a second end coupled tothe anchor portion, the anchor portion comprising a portion distal ofthe curved puncture portion. The delivery catheter can comprise a lumen,the puncture needle extending through the lumen, and a side outletopening on a distal portion of the delivery catheter configured to allowextension therethrough of at least a portion of the curved punctureportion, wherein the anchor portion extends through a distal portion ofthe lumen distal of the side outlet opening.

In some embodiments, the distal portion of the lumen distal of the sideoutlet opening comprises a lateral cross section comprising anon-circular shape, the lateral cross section being taken along a planeperpendicular to a longitudinal axis of the delivery catheter. In someembodiments, the lateral cross-section of the distal portion of thelumen comprises a same shape as a lateral cross section of the anchorportion.

In some embodiments, the system comprises a medical implant guide wiresheath configured to slidably receive a medical implant guide wire, themedical implant guide wire sheath comprising a distal portion coupled toat least a portion of the curved puncture portion.

In some embodiments, the anchor portion is a curved anchor portion, thecurved anchor portion comprising the portion distal of the curvedpuncture portion, and a proximal portion coupled to the second end ofthe curved puncture portion.

In some embodiments, the anchor portion comprises a first anchor portioncomprising a first end and a second end, wherein the first end of thefirst anchor portion is coupled to the curved puncture portion; and asecond anchor portion comprising a first end coupled to the second endof the first anchor portion, and wherein the second anchor portionextends proximally from the first end of the second anchor portion. Thefirst anchor portion and the second anchor portion can meet at a bend,and wherein the bend is proximally oriented and the bend is distal ofthe curved puncture portion.

In some embodiments, the curved puncture portion, the first anchorportion, and the second anchor portion are in one plane.

In some embodiments, the first anchor portion is a first curved anchorportion and the second anchor portion is a second curved anchor portion,wherein the curved puncture portion, the first curved anchor portion,and the second curved anchor portion comprise a same orientation.

In some embodiments, the first anchor portion and the second anchorportion are each linear portions.

In some embodiments, while the puncture needle is in a retracted state,the puncture tip is configured to be proximal of the side outlet openingand the anchor portion comprises a portion extending along the lumenpast the side outlet opening and through the portion of the lumen distalof the side outlet opening.

In some embodiments, while the puncture needle is in a retracted state,the puncture tip is configured to be distal of the side outlet openingand the anchor portion extends distally through the portion of the lumendistal of the side outlet opening.

In some implementations, a method for delivering a puncture needle cancomprise advancing a puncture needle system into a vessel. The punctureneedle system can comprise a puncture needle and a delivery catheter.The puncture needle can comprise a distal portion, the distal portioncomprising an anchor portion and a curved puncture portion comprising afirst end associated with a puncture tip and a second end coupled to theanchor portion, the anchor portion comprising a portion distal of thecurved puncture portion. The delivery catheter can comprise a punctureneedle lumen, the puncture needle extending slidably through thepuncture needle lumen, and a side outlet opening on a portion of thedelivery catheter configured to allow extension therethrough of at leasta portion of the curved puncture portion. The method can comprise one ofdistally or proximally translating the puncture needle relative to thedelivery catheter to release at least a portion of the curved punctureportion through the side outlet opening; and piercing tissue at a targettissue site to form an opening at the target tissue site using thepuncture tip extended through the side outlet opening.

In some embodiments, the system further comprises a medical implantguide wire sheath configured to slidably receive a medical implant guidewire, the medical implant guide wire sheath comprising a distal portioncoupled to at least a portion of the curved puncture portion, the methodfurther comprising advancing the medical implant guide wire within themedical implant guide wire sheath and through an opening associated witha distal end of the medical implant guide wire sheath into the openingformed at the target tissue site.

In some embodiments, advancing the puncture needle system into thevessel comprises advancing the puncture needle system into a coronarysinus. In some embodiments, piercing tissue at the target tissue sitecomprises piercing tissue on a left atrial wall.

For purposes of summarizing the disclosure, certain aspects, advantagesand novel features have been described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment. Thus, the disclosed embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are depicted in the accompanying drawings forillustrative purposes and should in no way be interpreted as limitingthe scope of the inventions. In addition, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure. Throughout the drawings, referencenumbers may be reused to indicate correspondence between referenceelements. However, it should be understood that the use of similarreference numbers in connection with multiple drawings does notnecessarily imply similarity between respective embodiments associatedtherewith. Furthermore, it should be understood that the features of therespective drawings are not necessarily drawn to scale, and theillustrated sizes thereof are presented for the purpose of illustrationof inventive aspects thereof. Generally, certain of the illustratedfeatures may be relatively smaller than as illustrated in someembodiments or configurations.

FIG. 1 is a cross-sectional view of a human heart.

FIG. 2 is another cross-sectional view of the human heart.

FIG. 3 shows an example of a puncture needle in accordance with one ormore embodiments.

FIG. 4 shows an example of a puncture needle comprising a plurality ofrounded bends on a distal portion of the puncture needle, in accordancewith one or more embodiments.

FIG. 5 shows an example of a puncture needle comprising an anchorportion which includes a first curved anchor portion and a second curvedanchor portion, in accordance with one or more embodiments.

FIG. 6 shows an example of a puncture needle comprising an anchorportion which includes a first anchor portion, a second anchor portion,a third anchor portion and a fourth anchor portion, in accordance withone or more embodiments.

FIG. 7 shows an example of a puncture needle comprising an anchorportion which includes a first anchor portion, a second anchor portion,a third anchor portion and a fourth anchor portion, in accordance withone or more embodiments.

FIGS. 8A and 8B show a puncture needle system comprising the punctureneedle of FIG. 3 in a retracted state and a deployed state,respectively, in accordance with one or more embodiments.

FIG. 9 shows a puncture needle system comprising a medical implant guidewire sheath, in accordance with one or more embodiments.

FIG. 10 shows an example of a puncture needle comprising a curved anchorportion and a proximally oriented curved puncture portion, in accordancewith one or more embodiments.

FIG. 11 shows an example of a puncture needle comprising a curved anchorportion and a distally oriented curved puncture portion, in accordancewith one or more embodiments.

FIG. 12 shows an example of a puncture needle comprising a curved anchorportion and a curved puncture portion, which are integrally formed, inaccordance with one or more embodiments.

FIGS. 13A and 13B show a puncture needle system comprising the punctureneedle described with reference to FIG. 10 in a retracted state and in adeployed state, respectively, in accordance with one or moreembodiments.

FIGS. 14A, 14B, 14C and 14D show another example of a puncture needlesystem, in accordance with one or more embodiments.

FIG. 15 is a flow diagram of an example of a process to deploy apuncture needle system for piercing tissue at a target tissue site, inaccordance with one or more embodiments.

DETAILED DESCRIPTION

The headings provided herein are for convenience only and do notnecessarily affect the scope or meaning of the claimed invention.

The present disclosure relates to devices, systems and methods forproviding minimally invasive transcatheter delivery of a puncture needleto a target tissue site on a vessel, channel, chamber and/or organ. Apuncture needle as described herein can have a configuration whichreduces or eliminates axial rotation of the puncture needle relative toa delivery catheter receiving the puncture needle, while the deliverycatheter and puncture needle are advanced through a tortuous anatomicalpathway to the target tissue site.

Although certain preferred embodiments and examples are disclosed below,inventive subject matter extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and tomodifications and equivalents thereof. Thus, the scope of the claimsthat may arise herefrom is not limited by any of the particularembodiments described below. For example, in any method or processdisclosed herein, the acts or operations of the method or process may beperformed in any suitable sequence and are not necessarily limited toany particular disclosed sequence. Various operations may be describedas multiple discrete operations in turn, in a manner that may be helpfulin understanding certain embodiments; however, the order of descriptionshould not be construed to imply that these operations are orderdependent. Additionally, the structures, systems, and/or devicesdescribed herein may be embodied as integrated components or as separatecomponents. For purposes of comparing various embodiments, certainaspects and advantages of these embodiments are described. Notnecessarily all such aspects or advantages are achieved by anyparticular embodiment. Thus, for example, various embodiments may becarried out in a manner that achieves or optimizes one advantage orgroup of advantages as taught herein without necessarily achieving otheraspects or advantages as may also be taught or suggested herein.

Certain standard anatomical terms of location are used herein to referto the anatomy of animals, and namely humans, with respect to thepreferred embodiments. Although certain spatially relative terms, suchas “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,”“horizontal,” “top,” “bottom,” and similar terms, are used herein todescribe a spatial relationship of one device/element or anatomicalstructure to another device/element or anatomical structure, it isunderstood that these terms are used herein for ease of description todescribe the positional relationship between element(s)/structures(s),as illustrated in the drawings. It should be understood that spatiallyrelative terms are intended to encompass different orientations of theelement(s)/structures(s), in use or operation, in addition to theorientations depicted in the drawings. For example, an element/structuredescribed as “above” another element/structure may represent a positionthat is below or beside such other element/structure with respect toalternate orientations of the subject patient or element/structure, andvice-versa.

In minimally invasive procedures, transcatheter delivery of a typicalpuncture needle into a vessel, channel, chamber and/or organ can bechallenging due to difficulty in reliably controlling the axialorientation of the puncture needle. The puncture needle may undesirablyrotate around its longitudinal axis when inserted through one or morebends in the anatomical pathway to reach a target site accessible fromwithin the vessel, channel, chamber and/or organ. The puncture needlecan be received within a delivery catheter. The typical puncture needlecan rotate axially relative to the delivery catheter while the deliverycatheter and/or the puncture needle is advanced to the target tissuesite, thereby resulting in the puncture needle becoming misalignedrelative to the delivery catheter. Misalignment of the puncture needlecan prevent deployment of the puncture needle from the delivery catheterand/or can shift the exit trajectory of the puncture needle as it isextended from the delivery catheter, thereby impeding effectivepuncturing of the tissue at the target tissue site.

Transcatheter delivery of a puncture needle into the coronary sinus canbe performed in procedures for forming an opening in the left atrialwall separating the coronary sinus from the left atrium. The opening inthe left atrial wall can be formed for the delivery of medical deviceimplants and/or therapies to the left atrial wall. For example, a shuntdevice can be delivered into the opening in the left atrial wall toprovide a blood flow conduit from the left atrium into the coronarysinus for treating elevated left atrial pressure. Transcatheter deliveryof a typical puncture needle into the coronary sinus can result inundesired axial rotation of the puncture needle within the deliverycatheter lumen, thereby leading to significant offset in the orientationof the puncture needle. Incorrect orientation of the puncture needlewithin the lumen can interfere with or prevent desired opening formationon the left atrial wall, which can contribute to improper placement ofthe medical device implant and/or inadequate therapy delivery.

The present disclosure provides devices, systems and methods relating tominimally invasive transcatheter delivery of a puncture needle to atarget tissue site. Described herein are puncture needles configured tomaintain a desired axial orientation as the puncture needles areinserted through one or more bends in the anatomical pathways to thetarget sites. In some embodiments, a puncture needle system can comprisea puncture needle and a delivery catheter configured to receive thepuncture needle. The delivery catheter can comprise a puncture needlelumen configured to receive the puncture needle, and a side outletopening on a distal portion configured to allow extension therethroughof the puncture needle for piercing the tissue. The puncture needle cancomprise one or more features configured to engage with a deliverycatheter lumen wall to prevent or reduce axial rotation of a distalportion of the puncture needle relative to the delivery catheter. Insome embodiments, the distal portion of the puncture needle can comprisean anchor portion and a curved puncture portion. The curved punctureportion can have a first end associated with a puncture tip configuredto pierce tissue and a second end coupled to the anchor portion. Theanchor portion can be configured to interact with the delivery catheterlumen wall to prevent or reduce axial rotation of the curved punctureportion. The anchor portion can comprise a portion which extendsdistally of the curved puncture portion. In some embodiments, theportion of the anchor portion extending distally of the curved punctureportion can engage with a portion of the delivery catheter lumen walldistal of the side outlet opening to prevent or reduce axial rotation ofthe curved puncture portion.

In some embodiments, the anchor portion can comprise a plurality ofportions which meet at one or more bends such that the curved punctureportion and the anchor portion can comprise a zig-zag shape. In someembodiments, the plurality of portions of the anchor portion can each belinear or substantially linear. For example, the plurality of portionsof the anchor portion can be linear or substantially linear in a relaxedstate. The linear or substantially linear portions can be flexible suchthat the portions of the anchor portion can assume a curvedconfiguration within the delivery catheter lumen when the deliverycatheter bends while being advanced through a tortuous anatomicalpathway. In some embodiments, the anchor portion can be one flexibleportion configured to assume a curved shape when positioned at orproximate to the target tissue site. In some embodiments, the pluralityof portions of the anchor portion can each be curved, for examplecomprising a pre-formed curvature. In some embodiments, the anchorportion can be one curved portion. For example, the anchor portion canbe a pre-formed curved portion. The one or more pre-formed curved anchorportions can be flexible to facilitate advancement of the punctureneedle through tortuous anatomical pathways and/or at or proximate tothe target tissue site.

In some embodiments, one or more of the puncture needles describedherein can comprise a curved puncture portion and/or anchor portionwhich has a lateral cross section which has a non-circular shape, suchas to provide a reduced profile for the puncture needles. In someembodiments, the lateral cross section can have a rectangular orsubstantially rectangular shape. Alternatively, in some embodiments, thelateral cross section can have a rounded shape, including a circular orsubstantially circular shape. The lateral cross section can be takenalong a plane perpendicular or substantially perpendicular to alongitudinal axis of the puncture needle.

In some embodiments, the puncture needles and/or puncture needle systemsdescribed herein can be configured for positioning into the coronarysinus to access a target site on the left atrial wall. A puncture needleas described herein can be used to form an opening on the left atrialwall such that a medical implant device, including a shunt device, suchas an expandable shunt device, can be positioned on the left atrialwall. The shunt device can provide a blood flow pathway from the leftatrium into the coronary sinus for relieving elevated left atrialpressure.

A puncture needle system can be advanced into the coronary sinus fromthe right atrium via the coronary sinus ostium. The right atrium can beaccessed via the superior vena cava (SVC) or via the inferior vena cava(IVC). A transjugular or trans-subclavian approach can be used to accessthe right atrium via the superior vena cava. Alternatively, atransfemoral approach can be used to position the puncture needle systeminto the inferior vena cava, and from the inferior vena cava into theright atrium. To access the coronary sinus, the puncture needle systemmay traverse one or more bends in the anatomical pathway. The one ormore bends can tend to axially rotate the puncture needle. For example,advancing the puncture needle system into the coronary sinus via thecoronary sinus ostium from the right atrium can involve one or morebends which can result in exertion of torsional force upon the punctureneedle, tending to rotate the puncture needle. The anchor portion canengage with one or more portions of the delivery catheter lumen wall toreduce or eliminate axial rotation of the curved puncture portion,effectively decoupling the axial orientation of the curved punctureportion from any axial rotations of portions of the puncture needleproximal of the curved puncture portion. The anchor portion can engagewith the portion of the delivery catheter lumen wall distal of the sideoutlet opening such that the axial orientation of the curved punctureportion is unaffected or substantially unaffected by axial rotation ofmore proximal portions of the puncture needle.

In some embodiments, one or more of the puncture needles describedherein can comprise an anchor portion and a curved puncture portionwhich are integrally formed. In some embodiments, the anchor portion andthe curved puncture portion can be integrally formed using one singleelongate portion. For example, the single elongate portion can be shapedfrom a single piece of material (e.g., a single piece of metallicmaterial, a single piece of polymeric material). In some embodiments, asingle piece of material can be split to provide the anchor portion andthe curved puncture portion. For example, the curved puncture portioncan be carved and/or cut from the piece of material to separate thecurved puncture portion from a remaining portion of the piece ofmaterial, the remaining portion comprising the anchor portion. In someembodiments, forming the anchor portion and the curved puncture portionfrom a single piece of material can reduce or eliminate locations moresusceptible to failure, such as locations at which two pieces ofmaterial are joined together. In some embodiments, the anchor portionand the curved puncture portion can be formed using a plurality ofdistinct pieces of material which are joined together (e.g., bonding,welding, gluing).

Although the puncture needles and/or puncture needle systems areprimarily described herein as being used to access the heart, it will beunderstood that the use of the puncture needles and/or puncture needlesystems are not so limited. The puncture needles and/or puncture needlesystems can be used to access any number of vessels, channels, chambersand/or organs which involve advancing the puncture needles and/orpuncture needle systems through anatomic pathways having one or morebends that can tend to axially rotate the puncture needles.

The term “associated with” is used herein according to its broad andordinary meaning. For example, where a first feature, element,component, device, or member is described as being “associated with” asecond feature, element, component, device, or member, such descriptionshould be understood as indicating that the first feature, element,component, device, or member is physically coupled, attached, orconnected to, integrated with, embedded at least partially within, orotherwise physically related to the second feature, element, component,device, or member, whether directly or indirectly.

Reference herein to “catheters” and/or “delivery catheters” can refer orapply generally to any type of elongate tubular delivery devicecomprising an inner lumen configured to slidably receiveinstrumentation, such as for positioning within an atrium or coronarysinus, including for example delivery sheaths and/or cannulas.

Various features of a heart 1 are described with reference to FIG. 1 toassist in understanding the present disclosure. The heart 1 includesfour chambers, namely the left atrium 2, the left ventricle 3, the rightventricle 4, and the right atrium 5. A wall of muscle, referred to asthe septum 10, separates the left atrium 2 and right atrium 5, and theleft ventricle 3 and right ventricle 4. Blood flow through the heart 1is at least partially controlled by four valves, the mitral valve 6,aortic valve 7, tricuspid valve 8, and pulmonary valve 9. The mitralvalve 6 separates the left atrium 2 and the left ventricle 3 andcontrols blood flow therebetween. The aortic valve 7 separates andcontrols blood flow between the left ventricle 3 and the aorta 12. Thetricuspid valve 8 separates the right atrium 5 and the right ventricle 4and controls blood flow therebetween. The pulmonary valve 9 separatesthe right ventricle 4 and the pulmonary artery 11, controlling bloodflow therebetween.

In a healthy heart, the heart valves can properly open and close inresponse to a pressure gradient present during various stages of thecardiac cycle (e.g., relaxation and contraction) to at least partiallycontrol the flow of blood to a respective region of the heart and/or toblood vessels. Deoxygenated blood arriving from the rest of the bodygenerally flows into the right side of the heart for transport to thelungs, and oxygenated blood from the lungs generally flows into the leftside of the heart for transport to the rest of the body. Duringventricular diastole, deoxygenated blood arrive in the right atrium 5from the inferior vena cava 15 and superior vena cava 16 to flow intothe right ventricle 4, and oxygenated blood arrive in the left atrium 2from the pulmonary veins to flow into the left ventricle 3. Duringventricular systole, deoxygenated blood from the right ventricle 4 canflow into the pulmonary artery 11 for transport to the lungs (e.g., viathe left 14 and right 13 pulmonary arteries), and oxygenated blood canflow from the left ventricle 3 to the aorta 12 for transport to the restof the body.

A number of conditions can contribute to a higher than normal pressurein the left atrium. Dysfunction of the mitral valve can contribute toelevated left atrial pressure. Conditions such as mitral valveregurgitation and/or stenosis may result in difficulty in pumping bloodfrom the left atrium to the left ventricle, contributing to elevatedpressure in the left atrium. Valve stenosis can cause a valve to becomenarrowed or obstructed. Mitral valve stenosis can restrict blood flowfrom the left atrium to the left ventricle. Valve regurgitation occurswhen a valve does not close properly. For example, regurgitation canoccur due to improper coaptation of the valve leaflets. Mitral valveregurgitation can result in blood flow leakage back into the left atrium2 from the left ventricle 3 when the left ventricle 3 contracts.Restricted flow of blood from the left atrium 2 into the left ventricle3, and blood flow leakage from the left ventricle 3 back into the leftatrium 2 can both contribute to elevated atrial pressure. Dysfunction inthe left ventricle 3 can also contribute to elevated left atrialpressure. Elevated left atrial pressure may lead to left atrialenlargement, producing symptoms such as shortness of breath duringexertion, fatigue, chest pain, fainting, abnormal heartbeat, andswelling of the legs and feet.

FIG. 2 is another view of the heart 1 and shows the coronary sinus 18around the left atrium 2. To alleviate elevated left atrial pressure, aconduit can be provided to allow blood flow from the left atrium 2 intoa portion of the heart with lower pressure, such as the coronary sinus18. A conduit can be formed on the wall of the left atrium 2 adjacent tothe coronary sinus 18 to allow blood flow from the left atrium 2 intothe coronary sinus 18. The coronary sinus 18 receives blood fromcoronary veins and empties into the right atrium 5. Blood diverted intothe coronary sinus 18 from the left atrium 2 can then be delivered intothe right atrium 5. A shunt device can be positioned at a location onthe left atrial wall, such as a location which is accessible from thecoronary sinus 18, to form a blood flow pathway from the left atrium 2into the coronary sinus 18. Access into the coronary sinus 18 cancomprise navigating into the right atrium 5 and entering through thecoronary sinus ostium 17.

FIG. 3 is a perspective view of an example of a puncture needle 100. Thepuncture needle 100 can be received within a delivery catheter while thedelivery catheter is advanced to a target tissue site. A distal portion102 of the puncture needle 100 can comprise a curved puncture portion120 and an anchor portion 170. For example, the puncture needle 100 cancomprise an elongate portion 110 and a distal portion 112 of theelongate portion 110 can comprise the curved puncture portion 120 andthe anchor portion 170. The puncture needle 100 can have a configurationwhich eliminates or reduces axial rotation of the curved punctureportion 120 within the delivery catheter as the delivery catheter isadvanced through a tortuous anatomical pathway. The anchor portion 170can be configured to engage with one or more portions of a lumen wall ofthe delivery catheter to reduce or eliminate rotation of the curvedpuncture portion 120 relative to the delivery catheter. The anchorportion 170 can comprise a portion which extends distally of the curvedpuncture portion 120. In some embodiments, the portion of the anchorportion 170 extending distally of the curved puncture portion 120 canengage with a corresponding portion of the wall of the delivery catheterlumen to facilitate maintaining a desired axial orientation for thecurved puncture portion 120. In some embodiments, both the anchorportion 170 and the curved puncture portion 120 can be configured toengage with one or more portions of the delivery catheter lumen wall toreduce or eliminate rotation of the curved puncture portion 120. Asdescribed in further detail herein, while the puncture needle 100 ispositioned within or substantially within the delivery catheter, such aswhile the puncture needle 100 is in a retracted state, the curvedpuncture portion 120 and the anchor portion 170 can engage withcorresponding portions of the delivery catheter lumen wall to prevent orreduce axial rotation of the curved puncture portion 120.

The curved puncture portion 120 can comprise a first end 122 associatedwith a puncture tip 180. The puncture tip 180 can be configured topierce tissue at the target tissue site. The curved puncture portion 120can comprise a second end 124 coupled to the anchor portion 170. Aradius of curvature of the curved puncture portion 120 can be selectedto facilitate tissue puncture and/or formation of a desired opening atthe target tissue site. The curvature can facilitate insertion of thepuncture needle 100 into the tissue at the target tissue site as thecurved puncture portion 120 is extended from the delivery catheter. Thecurved puncture portion 120 can comprise a pre-formed curvatureconfigured to facilitate accessing the target tissue site while thepuncture needle 100 is positioned in a vessel, channel, chamber and/ororgan to facilitate effective puncture of the target tissue site. Forexample, in a relaxed state, the radius of curvature of the pre-formedcurvature of the curved puncture portion 120 can facilitate accessingand/or puncturing a target tissue site on a left atrial wall while thecurved puncture portion 120 is extended from a side outlet opening of adelivery catheter positioned in a coronary sinus. The curved punctureportion 120 can comprise a shape memory material such that the curvedpuncture portion 120 can assumed the curved configuration after it isreleased from the delivery catheter lumen. In some embodiments, thecurved puncture portion 120 can comprise a segment of a circle. Forexample, the curved puncture portion 120 can comprise a semi-circle.Referring to FIG. 3, the curved puncture portion 120 can be orientedproximally. For example, an inner edge of the curved puncture portion120 can comprise at least a portion which is oriented proximally, suchthat at least a portion of the concave portion of the curved punctureportion 120 is proximally oriented. In some embodiments, the puncturetip 180 can point proximally. In some embodiments, the puncture tip 180can point laterally.

Referring to FIG. 3, the anchor portion 170 can comprise a first anchorportion 130 and a second anchor portion 140. The first anchor portion130 can comprise a first end 132 and a second end 134. The first end 132of the first anchor portion 130 can be coupled to the second end 124 ofthe curved puncture portion 120. For example, the first end 132 of thefirst anchor portion 130 can meet the second end 124 of the curvedpuncture portion 120 at a first bend 126. The first bend 126 can beoriented distally or substantially distally. In some embodiments, atleast a portion of the concave portion of the first bend 126 is distallyoriented. For example, the first bend 126 can comprise an acute angle,where the acute angle is oriented distally or substantially distally.

The first anchor portion 130 and the second anchor portion 140 can meetat a second bend 136. The second anchor portion 140 can comprise a firstend 142 and the first end 142 of the second anchor portion 140 can becoupled to the second end 134 of the first anchor portion 130. The firstend 142 of the second anchor portion 140 and the second end 134 of thefirst anchor portion 130 can meet at the second bend 136. The secondbend 136 can be oriented proximally or substantially proximally. In someembodiments, at least a portion of the concave portion of the secondbend 136 is proximally oriented. For example, the second bend 136 cancomprise an acute angle, and the acute angle can be oriented proximallyor substantially proximally. In some embodiments, the first bend 126 andthe second bend 136 can comprise opposing or substantially opposingorientations. In some embodiments, the first bend 126 and the secondbend 136 can each comprise an acute angle, and the acute angles cancomprise opposing or substantially opposing orientations. The secondanchor portion 140 can extend proximally from the first end 142.

In some embodiments, the first anchor portion 130 and the second anchorportion 140 can each comprise a linear or substantially linear portion.As described herein, the first bend 126 and the second bend 136 can eachcomprise an acute angle and have opposing or substantially opposingorientations. The curved puncture portion 120 and the anchor portion 170together can comprise a zig-zag shape. In some embodiments, the firstanchor portion 130 and the second anchor portion 140 can each be alinear or substantially linear portion, such that the curved punctureportion 120 and the anchor portion 170 together can comprise a “z”shape. In some embodiments, the first anchor portion 130 and the secondanchor portion 140 can be flexible such that the first anchor portion130 and the second anchor portion 140 can assume a curved configurationto conform to a curvature of a vessel, channel, chamber and/or organinto which the anchor portion 170 is positioned. In some embodiments,flexibility of the first anchor portion 130 and the second anchorportion 140 can facilitate advancement of the puncture needle 100through tortuous anatomical pathways.

In some embodiments, the curved puncture portion 120 and the anchorportion 170 can be in the same plane and/or parallel planes. The curvedpuncture portion 120 and the anchor portion 170 can lay flat orsubstantially flat when laid on a side. For example, the curved punctureportion 120, the first anchor portion 130 and the second anchor portion140 can all extend along lines contained in the same plane. In someembodiments, the curved puncture portion 120, the first anchor portion130 and the second anchor portion 140, and the puncture tip 180 can allbe in the same plane. In some embodiments, the curved puncture portion120 and the anchor portion 170 can comprise corresponding portions inthe same plane. For example, respective portions of the curved punctureportion 120, the first anchor portion 130 and the second anchor portion140 can extend along lines contained in the same plane, such that thecurved puncture portion 120, the first anchor portion 130 and the secondanchor portion 140 each comprise portions which extend along linescontained in parallel planes.

In some embodiments, the curved puncture portion 120 can comprise alateral cross section comprising a rounded shape, including a circularor substantially circular shape. Alternatively, the lateral crosssection can comprise a non-circular shape, including a polygonal shape,such as a rectangular or substantially rectangular shape. Thenon-circular cross-sectional shape can provide a reduced profile for thepuncture needle 100. The lateral cross section of the curved punctureportion 120 can be taken along a plane perpendicular or substantiallyperpendicular to a concavity of the curvature. In some embodiments, theanchor portion 170 can comprise a lateral cross section comprising arounded shape, including a circular shape. Alternatively, the lateralcross section can comprise a non-circular shape, including a polygonalshape, such as a rectangular or substantially rectangular shape, forexample to provide a reduced profile for the puncture needle 100. Insome embodiments, a lateral cross section of a portion of the anchorportion 170 can be taken along a plane perpendicular or substantiallyperpendicular to a longitudinal axis of the puncture needle 100 and/or alongitudinal axis of the portion of the anchor portion 170.

In some embodiments, the curved puncture portion 120 and the anchorportion 170 can be integrally formed. In some embodiments, the curvedpuncture portion 120 and the anchor portion 170 can be a part of asingle elongate portion. For example, a distal portion 112 of theelongate portion 110 can comprise the curved puncture portion 120, thefirst anchor portion 130 and the second anchor portion 140. The firstanchor portion 130 can be a first distal elongate portion. The secondanchor portion 140 can be a second distal elongate portion. As describedherein, the curved puncture portion 120 can have the puncture tip 180associated with the first end 122. The curved puncture portion 120 canextend from the first end 122 to the first bend 126. The first bend 126can have a first acute angle oriented distally. The first distalelongate portion, or the first anchor portion 130, can meet the curvedpuncture portion 120 at the first bend 126. The first distal elongateportion can extend from the first bend 126 to the second bend 136. Thesecond bend 136 can have a second acute angle oriented proximally. Thefirst distal elongate portion can meet the second distal elongateportion, or the second anchor portion 140, at the second bend 136. Thesecond distal elongate portion can extend proximally from the secondbend 136. The second bend 136 can be distal of the curved punctureportion 120.

In some embodiments, the first bend 126 and the second bend 136 can eachcomprise a sharp and/or pointed bend. In some embodiments, the sharpand/or pointed bends can facilitate a reduced profile for the distalportion 102 of the puncture needle 100.

As described herein, the anchor portion 170 can comprise at least aportion which is distal of the curved puncture portion 120. A portion ofthe first anchor portion 130 and a portion of the second anchor portion140 can be distal of the curved puncture portion 120. For example, thesecond bend 136 can be distal of the curved puncture portion 120. Insome embodiments, the portion of the anchor portion 170 distal of thecurved puncture portion 120 can engage with one or more portions of thedelivery catheter lumen wall to facilitate maintaining a desiredorientation of the curved puncture portion 120. The puncture needle 100can be pre-loaded within the delivery catheter lumen, for example thecurved puncture portion 120 and the anchor portion 170 being positionedproximate or adjacent to a side outlet opening configured to allowextension therethrough of the puncture needle 100.

As described in further detail herein, the anchor portion 170 cancomprise a portion configured to be received in the portion of thedelivery catheter lumen distal of the side outlet opening, both whilethe puncture needle 100 is in a retracted state and a deployed state.Having the anchor portion 170 engage and/or interact with the portion ofthe lumen wall distal of the side outlet opening, for example ratherthan with any portion of the lumen wall proximal of the side outletopening, can facilitate stabilization of the axial orientation of theanchor portion 170, thereby facilitating stabilization of the axialorientation of the curved puncture portion 120. The desired axialorientation of the curved puncture portion 120 can be maintained orsubstantially maintained regardless of torsional forces exerted upon thepuncture needle 100 and/or any rotations of the proximal portion of thepuncture needle 100 while the delivery catheter is advanced throughtortuous anatomical pathways. Engaging the anchor portion 170 with theportion of the delivery catheter lumen wall distal of the side outletopening can decouple any axial rotation of the proximal portion of thepuncture needle 100 from the curved puncture portion 120, allowing thecurved puncture portion 120 to remain aligned relative to the deliverycatheter. In some embodiments, the curved puncture portion 120 canexhibit no or reduced rotation around a longitudinal axis of thepuncture needle 100 while the puncture needle 100 is positioned withinthe delivery catheter lumen and while the delivery catheter is advancedthrough a tortuous anatomical pathway to the target tissue site.

In some embodiments, both the curved puncture portion 120 and the anchorportion 170 can engage with corresponding portions of the deliverycatheter lumen wall to prevent or reduce axial rotation of the curvedpuncture portion 120. For example, the bends 126, 136 in the distalportion 102 can render the curved puncture portion 120 and the anchorportion 170 to have a tendency to extend radially. For example, thecurved puncture portion 120 and the anchor portion 170 can bespring-loaded. The tendency to extend radially can increase contactbetween the puncture needle 100 and the lumen wall of the deliverycatheter. Increased contact between the puncture needle 100 and thelumen wall can facilitate fixation of the position and/or orientation ofthe curved puncture portion 120, reducing or preventing rotation of thecurved puncture portion 120. In some embodiments, the tendency of theanchor portion 170 and curved puncture portion 120 to extend radiallycan facilitate extension of the curved puncture portion 120 through theside outlet opening when deploying the puncture needle 100.

FIG. 4 shows an example of a puncture needle 200. A distal portion 202of the puncture needle 200 can comprise a plurality of bends each ofwhich can have a rounded configuration. The distal portion 202 of thepuncture needle 200 can comprise a curved puncture portion 220 and ananchor portion 270. The anchor portion 270 can comprise at least aportion which extends distally of the curved puncture portion 220. Insome embodiments, the puncture needle 200 can comprise an elongateportion 210 and a distal portion 212 of the elongate portion 210 cancomprise the curved puncture portion 220 and the anchor portion 270.

Referring to FIG. 4, the curved puncture portion 220 can comprise afirst end 222 associated with a puncture tip 280 and a second end 224coupled to the anchor portion 270. The curved puncture portion 220 cancomprise one or more features of the curved puncture portion 120described with reference to FIG. 3. For example, the curved punctureportion 220 can comprise a segment of a circle, such as a semi-circle.In some embodiments, the curved puncture portion 220 can be orientedproximally. In some embodiments, the puncture tip 280 can pointproximally. In some embodiments, the puncture tip 280 can pointlaterally.

The anchor portion 270 can comprise a first anchor portion 230comprising a first end 232 and a second end 234, and a second anchorportion 240 comprising a first end 242. The first end 232 of the firstanchor portion 230 can be coupled to the second end 224 of the curvedpuncture portion 220. For example, the first end 232 of the first anchorportion 230 can meet the second end 224 of the curved puncture portion220 at a first bend 226. As shown in FIG. 4, the first bend 226 can beoriented distally or substantially distally. For example, the concaveportion of the first bend 226 can comprise at last a portion which isoriented distally or substantially distally. The first anchor portion230 and the second anchor portion 240 can meet at a second bend 236. Thefirst end 242 of the second anchor portion 240 can be coupled to thesecond end 234 of the first anchor portion 230. The first end 242 of thesecond anchor portion 240 and the second end 234 of the first anchorportion 230 can meet at the second bend 236. In some embodiments, thefirst bend 226 and the second bend 236 can comprise opposing orsubstantially opposing orientations. The second bend 236 can be orientedproximally or substantially proximally. For example, the concave portionof the second bend 236 can comprise at last a portion which is orientedproximally or substantially proximally. The second anchor portion 240can extend proximally from the second bend 236.

In some embodiments, one or both of the first bend 226 and the secondbend 236 can be rounded, for example comprising an arcuate shape. One orboth of the first bend 226 and the second bend 236 can comprise asegment of a circle or an oval. In some embodiments, both the first bend226 and the second bend 236 can be rounded, for example comprising asegment of a circle. In some embodiments, while in a relaxed state, suchas when the puncture needle 200 is not within delivery catheter lumen,the first anchor portion 230 and the second anchor portion 240 can beparallel or substantially parallel to one another. In some embodiments,the second bend 236 can comprise a semi-circle. In some embodiments, thefirst bend 226 can comprise a semi-circle. In some embodiments, thefirst anchor portion 230 and the second anchor portion 240 are notparallel to one another. In some embodiments, the second bend 236 cancomprise an acute angle. The acute angle can be oriented proximally orsubstantially proximally, for example a concave portion of the secondbend 236 can be oriented proximally or substantially proximally.

The first bend 226 and the second bend 236 can each be sized such thatopposing portions of each of the first bend 226 and the second bend 236can contact opposing portions of the delivery catheter lumen wall. Insome embodiments, contact between the bends 226, 236 and the deliverycatheter lumen wall can reduce or prevent axial rotation of the distalportion 202 of the puncture needle 200, thereby maintaining the desiredorientation of the curved puncture portion 220.

In some embodiments, engagement of the anchor portion 270 and thedelivery catheter lumen wall can prevent or reduce axial rotation of thecurved puncture portion 220. A portion of the anchor portion 270 distalof the curved puncture portion 220 can be received in the portion of thedelivery catheter lumen distal of a side outlet opening of the deliverycatheter both while the puncture needle 200 is in a retracted state anda deployed state. A portion of the first anchor portion 230 and aportion of the second anchor portion 240 can be distal of the curvedpuncture portion 220. For example, the second bend 236 can be distal ofthe curved puncture portion 220. In some embodiments, the portion of theanchor portion 270 distal of the curved puncture portion 220 can engagewith one or more portions of the delivery catheter lumen wall distal ofthe side outlet opening to facilitate maintaining a desired orientationof the curved puncture portion 220. In some embodiments, both the curvedpuncture portion 220 and the anchor portion 270 can engage withcorresponding portions of the delivery catheter lumen wall to prevent orreduce axial rotation of the curved puncture portion 220.

The puncture needle 200 can one or more other features of the punctureneedle 100 described with reference to FIG. 3. For example, the firstanchor portion 230 and the second anchor portion 240 can each comprise alinear or substantially linear portion. The first anchor portion 230 andthe second anchor portion 240 can each be a linear or substantiallylinear portion. In some embodiments, the curved puncture portion 220 andthe anchor portion 270 together can form a zig-zag shape, including forexample a “z” shape. In some embodiments, the first anchor portion 230and the second anchor portion 240 can be flexible such that anchorportions 230, 240 can assume a curved configuration to conform to acurvature of a vessel, channel, chamber and/or organ into which theanchor portion 270 is positioned. Flexibility of the first anchorportion 230 and the second anchor portion 240 can facilitate advancementof the puncture needle 200 through tortuous anatomical pathways.

In some embodiments, the curved puncture portion 220 and the anchorportion 270 can be in the same plane and/or parallel planes, for exampleextending along lines which are in the same plane and/or parallelplanes. In some embodiments, the curved puncture portion 220, the firstanchor portion 230, the second anchor portion 240, the first bend 226,the second bend 236, and the puncture tip 280 can all be in the sameplane. The curved puncture portion 220 and the anchor portion 270 canlay flat or substantially flat when laid on a side. In some embodiments,the curved puncture portion 220 and the anchor portion 270 can comprisecorresponding portions in the same plane. For example, respectiveportions of the puncture tip 280, the curved puncture portion 220, thefirst anchor portion 230, the first bend 226, the second anchor portion240, and the second bend 236 can extend along lines contained in thesame plane, such that the puncture tip 280, the curved puncture portion220, the first anchor portion 230, the first bend 226, the second anchorportion 240, and the second bend 236 each comprise portions which extendalong lines contained in parallel planes.

In some embodiments, the curved puncture portion 220 and the anchorportion 270 can be integrally formed. In some embodiments, the curvedpuncture portion 220 and the anchor portion 270 can be a part of asingle elongate portion. For example, a distal portion 212 of theelongate portion 210 can comprise the curved puncture portion 220, thefirst bend 226, the first anchor portion 230, the second bend 236, andthe second anchor portion 240. A lateral cross section of the curvedpuncture portion 220, the first bend 226, the first anchor portion 230,the second bend 236 and the second anchor portion 240 can comprise alateral cross section comprising a rounded shape, including a circularshape. Alternatively, the lateral cross section can comprise anon-circular shape, including a polygonal shape, such as a rectangularshape. In some embodiments, a lateral cross section of the curvedpuncture portion 220, the first bend 226, and the second bend 236 can betaken along a plane perpendicular or substantially perpendicular to aconcavity of the respective concavity. In some embodiments, a lateralcross section of the first anchor portion 230 and the second anchorportion 240 can be taken along a plane perpendicular or substantiallyperpendicular to a longitudinal axis of the respective portion of theanchor portion 270 and/or the puncture needle 200.

FIG. 5 shows an example of a puncture needle 300 comprising an anchorportion 370 which includes a first curved anchor portion 330 and asecond curved anchor portion 340. The first curved anchor portion 330and the second curved anchor portion 340 can each comprise a pre-formedcurvature. A distal portion 302 of the puncture needle 300 can comprisea curved puncture portion 320 and the anchor portion 370. For example,an elongate portion 310 of the puncture needle 300 can comprise a distalportion 312 which can include the curved puncture portion 320 and theanchor portion 370.

The curved puncture portion 320 can comprise one or more features of thecurved puncture portion 120 described with reference to FIG. 3. Thecurved puncture portion 320 can comprise a first end 322 associated witha puncture tip 380 and a second end 324 coupled to the anchor portion370. The curved puncture portion 320 can comprise a segment of a circle,such as a semi-circle. In some embodiments, the curved puncture portion320 can be oriented proximally. In some embodiments, the puncture tip380 can point proximally. In some embodiments, the puncture tip 380 canpoint laterally.

The first curved anchor portion 330 and the second curved anchor portion340 can comprise the same orientation. In some embodiments, the firstcurved anchor portion 330 and the second curved anchor portion 340 cancomprise the same orientation as the curved puncture portion 320. Forexample, a corresponding concave portion of the first curved anchorportion 330 and the second curved anchor portion 340 can comprise atleast a portion which is oriented proximally or substantiallyproximally. A radius of curvature of each of the first curved anchorportion 330 and the second curved anchor portion 340 can be selectedbased at least on a shape of the desired vessel, channel, chamber and/ororgan into which the puncture needle 300 is advanced for accessing thetarget tissue site. For example, the radius of curvature of the firstcurved anchor portion 330 and the second curved anchor portion 340 canbe selected based on a radius of curvature of the portion of thecoronary sinus into which the anchor portion 370 is advanced. The anchorportion 370 can be shaped to follow a length of the curvature of thecoronary sinus. In some embodiments, the radius of curvature for each ofthe first curved anchor portion 330 and the second curved anchor portion340 can be greater than that of the curved puncture portion 320. Forexample, the degree of curvature of the curved puncture portion 320 caneach be greater than that of the curved anchor portions 330, 340.

The curved puncture portion 320 can be coupled to the first curvedanchor portion 330 at a first bend 326. A first end 332 of the firstanchor portion 330 can meet the second end 324 of the curved punctureportion 320 at the first bend 326. The first bend 326 can be orienteddistally or substantially distally. The first curved anchor portion 330can be coupled to the second curved anchor portion 340 at a second bend336. A first end 342 of the second anchor portion 340 can meet a secondend 334 of the first anchor portion 330 at the second bend 336. In someembodiments, the first bend 326 and the second bend 336 can compriseopposing or substantially opposing orientations. The second bend 336 canbe oriented proximally or substantially proximally. In some embodiments,the first bend 326 can comprise an acute angle, where the acute angle isoriented distally or substantially distally. In some embodiments, thesecond bend 336 can comprise an acute angle, and the acute angle can beoriented proximally or substantially proximally. The second anchorportion 340 can extend proximally from the second bend 336. In someembodiments, the first bend 326 and the second bend 336 can eachcomprise an acute angle such that the curved puncture portion 320 andthe anchor portion 370 can comprise a zig-zag shape.

A portion of the anchor portion 370 can be distal of the curved punctureportion 320. For example, a portion of the first anchor portion 330 anda portion of the second anchor portion 340 can be distal of the curvedpuncture portion 320. The second bend 336 can be distal of the curvedpuncture portion 320. In some embodiments, the portion of the anchorportion 370 distal of the curved puncture portion 320 can engage withthe delivery catheter lumen wall distal of a side outlet opening toprevent or reduce axial rotation of the curved puncture portion 320. Insome embodiments, both the curved puncture portion 320 and the anchorportion 370 can engage with corresponding portions of the deliverycatheter lumen wall to prevent or reduce axial rotation of the curvedpuncture portion 320.

In some embodiments, a lateral cross section of the curved punctureportion 320 and/or the anchor portion 370 can be non-circular. Thelateral cross section can be taken along a plane perpendicular orsubstantially perpendicular to the concavity of the curved punctureportion 320 and/or respective portion of the anchor portion 370. Thelateral cross section can be selected to reduce a profile of thepuncture needle 300. In some embodiments, the lateral cross section cancomprise a polygonal shape, such as a rectangular or substantiallyrectangular shape. In some embodiments, as described in further detailherein, the lateral cross section of the anchor portion 370 can beselected to correspond to a lateral cross section of the portion of thedelivery catheter lumen distal of the side outlet opening to facilitateengagement of the anchor portion 370 with the lumen wall. Improvedengagement between the anchor portion 370 and the lumen wall canfacilitate maintaining the desired orientation of the curved punctureportion 320. The concavity of the curved puncture portion 320 and/or theanchor portion 370 can generally be normal to the long flat surface ofthe rectangular-cross-sectional form thereof, as in the diagram of FIG.5. Alternatively, a lateral cross section of the curved puncture portion320 and/or the anchor portion 370 can comprise a rounded shape, such asa circular shape.

In some embodiments, the curved puncture portion 320 and the anchorportion 370 can be in the same plane and/or parallel planes, for exampleextending along lines which are in the same plane and/or parallelplanes. In some embodiments, the curved puncture portion 320, the firstanchor portion 330, the second anchor portion 340 and the puncture tip380 can all be in the same plane. The curved puncture portion 320 andthe anchor portion 370 can lay flat or substantially flat when laid on aside. In some embodiments, the curved puncture portion 320 and theanchor portion 370 can comprise corresponding portions in the sameplane. For example, respective portions of the curved puncture portion320, the first anchor portion 330, the second anchor portion 340 and thepuncture tip 380 can extend along lines contained in the same plane,such that the curved puncture portion 320, the first anchor portion 330,the second anchor portion 340 and the puncture tip 380 each compriseportions which extend along lines contained in parallel planes. In someembodiments, the curved puncture portion 320 and the anchor portion 370can be integrally formed, for example being a part of a single elongateportion. For example, a distal portion 312 of the elongate portion 310can comprise the curved puncture portion 320, the first anchor portion330 and the second anchor portion 340. The first anchor portion 330 canbe a first distal curved portion and the second anchor portion 340 canbe a second distal curved portion.

FIG. 6 shows an example of a puncture needle 400 comprising an anchorportion 470 which includes a first anchor portion 430, a second anchorportion 440, a third anchor portion 450 and a fourth anchor portion 460.A distal portion 402 of the puncture needle 400, such as a distalportion 412 of an elongate portion 410 of the puncture needle 400, cancomprise the anchor portion 470. The anchor portion 470 can be coupledto a curved puncture portion 420. The curved puncture portion 420 canmeet the first anchor portion 430 at a first bend 426. For example, afirst end 432 of the first anchor portion 430 can be coupled to a secondend 424 of the curved puncture portion 420 at the first bend 426. Thefirst bend 426 can be oriented distally or substantially distally. Thefirst anchor portion 430 can meet the second anchor portion 440 at asecond bend 436. A second end 434 of the first anchor portion 430 can becoupled to a first end 442 of the second anchor portion 440 at thesecond bend 436. The second bend 436 can be oriented proximally orsubstantially proximally. The second anchor portion 440 can meet thethird anchor portion 450 at a third bend 446. For example, a second end444 of the second curved anchor portion 440 can be coupled to a firstand 452 of the third curved anchor portion 450 at the third bend 446.The third bend 446 can be oriented distally or substantially distally.The third anchor portion 450 can meet the fourth anchor portion 460 at afourth bend 456. A second and 454 of the third curved anchor portion 450can be coupled to a first end 462 of the third curved anchor portion for460 at the fourth bend 456. In some embodiments, the fourth bend 456 canbe oriented proximally or substantially proximally. The fourth anchorportion 460 can extend proximally from the fourth bend 456.

In some embodiments, each of the first bend 426, the second bend 436,the third bend 446 and the fourth bend 456 can each comprise an acuteangle. In some embodiments, adjacent bends can have opposing orsubstantially opposing orientations. For example, the first bend 426 cancomprise an acute angle oriented distally or substantially distally. Thesecond bend 436 can comprise an acute angle oriented proximally orsubstantially proximally. The third bend 446 can comprise an acute angleoriented distally or substantially distally. The fourth bend 456 cancomprise an acute angle oriented proximally or substantially proximally.In some embodiments, each of the first anchor portion 430, the secondanchor portion 440, the third anchor portion 450, and the fourth anchorportion for 460 can comprise a linear or substantially linear portion.For example, each of the first anchor portion 430, the second anchorportion 440, the third anchor portion 450, and the fourth anchor portion460 can be linear or substantially linear such that the anchor portion470 comprises a zig-zag shape. In some embodiments, the first anchorportion 430, the second anchor portion 440, the third anchor portion450, and the fourth anchor portion 460 can be flexible such that anchorportions 430, 440, 450, 460 can assume a curved configuration to conformto a curvature of a vessel, channel, chamber and/or organ into which theanchor portion 470 is positioned. Alternatively, in some embodiments,each of the anchor portions 430, 440, 450, 460 can comprise a pre-formedcurvature to conform to the curvature of the vessel, channel, chamberand/or organ. In some embodiments, the anchor portions 430, 440, 450,460 can assume a curved configuration and/or have a pre-formed curvatureto facilitate advancement of the puncture needle 400 through tortuousanatomical pathways.

A portion of the anchor portion 470 can be distal of the curved punctureportion 420. For example, at least a portion of each of the first anchorportion 430, the second anchor portion 440, the third anchor portion450, and the fourth anchor portion 460, can be distal of the curvedpuncture portion 420. The second bend 436 and the fourth bend 456 can bedistal of the curved puncture portion 420. The portion of the anchorportion 470 distal of the curved puncture portion 420 can engage withthe delivery catheter lumen wall distal of a side outlet opening. Insome embodiments, both the curved puncture portion 420 and the anchorportion 470 can engage with corresponding portions of the deliverycatheter lumen wall to prevent or reduce axial rotation of the curvedpuncture portion 420.

FIG. 6 shows the second bend 436 distal of the fourth bend 456. In someembodiments, the second bend 436 can be proximal of the fourth bend 456.In some embodiments, having one of the second bend 436 or the fourthbend 456 distal of the other can facilitate improved engagement with thedelivery catheter lumen wall distal of the side outlet opening, whilemaintaining a reduced distal profile for the puncture needle 400. Insome embodiments, the second bend 436 and the third fourth 456 can be ata similar or same distal position.

The curved puncture portion 420 can comprise one or more features of thecurved puncture portion 120 described with reference to FIG. 3. Thecurved puncture portion 420 can comprise a first end 422 associated witha puncture tip 480. The second end 424 can coupled to the anchor portion470. In some embodiments, the curved puncture portion 420 can comprise asegment of a circle, for example comprising a semi-circle. The curvedpuncture portion 420 can be oriented proximally or substantiallyproximally. In some embodiments the puncture tip 480 can pointproximally. In some embodiments the puncture tip 480 can pointlaterally. In some embodiments, the curved puncture portion 420 and theanchor portion 470 can be integrally formed, for example being a part ofa single elongate portion.

FIG. 7 shows an example of a puncture needle 500 comprising a distallyor substantially distally oriented curved puncture portion 520. A distalportion 502 of the puncture needle 500 can comprise the curved punctureportion 520 and an anchor portion 570. The anchor portion 570 can becoupled to the curved puncture portion 520. For example, a distalportion 512 of an elongate portion 510 of the puncture needle 500 cancomprise the anchor portion 570 and the curved puncture portion 520. Theconcave portion of the curved puncture portion 520 can comprise at leasta portion which is oriented distally or substantially distally. In someembodiments the puncture tip 580 can point distally. In some embodimentsthe puncture tip 580 can point laterally. The curved puncture portion520 can comprise one or more other features of the curved punctureportion 120 described with reference to FIG. 3. For example, the curvedpuncture portion 520 can comprise a first end 522 associated with apuncture tip 580, and a second end 524 coupled to the anchor portion570. In some embodiments, the curved puncture portion 520 can comprise asegment of a circle, for example comprising a semi-circle.

The puncture needle 500 can comprise one or more other features of thepuncture needle 400 described with reference to FIG. 6. In someembodiments, the puncture needle 500 can comprise the other features ofthe puncture needle 400. For example, the anchor portion 570 cancomprise a first anchor portion 530, a second anchor portion 540, athird anchor portion 550 and a fourth anchor portion 560. A first end532 of the first anchor portion 530 can be coupled to the second end 524of the curved puncture portion 520. A second end 534 of the first anchorportion 530 can be coupled to a first end 542 of the second anchorportion 540 at a first bend 536. The first bend 536 can be orientedproximally or substantially proximally. A second end 544 of the secondcurved anchor portion 540 can be coupled to a first end 552 of the thirdcurved anchor portion 550 at a second bend 546. The second bend 546 canbe oriented distally or substantially distally. A second end 554 of thethird curved anchor portion 550 can be coupled to a first end 562 of thethird curved anchor portion for 560 at a third bend 556. The third bend556 can be oriented proximally or substantially proximally. The fourthanchor portion 560 can extend proximally from the third bend 556.

In some embodiments, each of the first bend 536, the second bend 546 andthe third bend 556 can comprise an acute angle. The first bend 536 cancomprise an acute angle oriented proximally or substantially proximally.The second bend 546 can comprise an acute angle oriented distally orsubstantially distally. The third bend 556 can comprise an acute angleoriented proximally or substantially proximally. The first bend 536 canbe distal, proximal, or at a same or similar distal position, as thethird bend 556. In some embodiments, each of the first anchor portion530, the second anchor portion 540, the third anchor portion 550, andthe fourth anchor portion 560 can comprise a linear or substantiallylinear portion. For example, each of the first anchor portion 530, thesecond anchor portion 540, the third anchor portion 550, and the fourthanchor portion 560 can be linear or substantially linear such that theanchor portion 570 comprises a zig-zag shape. In some embodiments, theanchor portions 530, 540, 550, 560 can be flexible such that the anchorportions 530, 540, 550, 560 can assume a curved configuration to followa curvature of a vessel, channel, chamber and/or organ into which theanchor portion 570 is positioned. Alternatively, in some embodiments,each of the anchor portions 530, 540, 550, 560 can comprise a pre-formedcurvature to conform to the curvature of the vessel, channel, chamberand/or organ. In some embodiments, the anchor portions 530, 540, 550,560 can assume a curved configuration and/or have a pre-formed curvatureto facilitate advancement of the puncture needle 500 through tortuousanatomical pathways.

The puncture needles 400, 500 described with reference to FIGS. 6 and 7can have one or more other features of the puncture needle 100 describedwith reference to FIG. 3. For example, the curved puncture portions 420,520 and the anchor portions 470, 570 of the puncture needles 400, 500described with reference to FIGS. 6 and 7 can be in the same planeand/or parallel planes, for example extending along lines which are inthe same plane and/or parallel planes. In some embodiments, the curvedpuncture portion 520, the anchor portion 570, and the puncture tip 580can all be in the same plane. The curved puncture portions 420, 520 andthe anchor portions 470, 570 can comprise respective portions in thesame plane. The respective portions of the curved puncture portions 420,520 and the anchor portions 470, 570 can extend along lines contained inthe same plane, such that the curved puncture portions 420, 520 and theanchor portions 470, 570 each comprise portions which extend along linescontained in parallel planes. In some embodiments, the curved punctureportion 520 and the anchor portion 570 can be integrally formed, forexample being a part of a single elongate portion.

A lateral cross section of the puncture needles 400, 500 described withreference to FIGS. 6 and 7 can each comprise a rounded (e.g., a circularshape), or alternatively, non-circular, such as a polygonal shape. Forexample, each of the curved puncture portions 420, 520 and anchorportions 470, 570 can comprise a lateral cross section comprising arounded shape, including a circular shape. Alternatively, the lateralcross section can comprise a rectangular shape. A lateral cross sectionof the curved puncture portions 420, 520 can be taken along a planeperpendicular or substantially perpendicular to a respective concavityof the curved puncture portions 420, 520. A lateral cross section of theanchor portions 470, 570 can be taken along a plane perpendicular orsubstantially perpendicular to a longitudinal axis of the respectivepuncture needles 400, 500 and/or the respective anchor portion.

Although the puncture needles 400, 500 described with reference to FIGS.6 and 7 each comprise anchor portions 470, 570 which include fourdistinct portions, it will be understood that an anchor portion cancomprise more distinct portions. For example, an anchor portion cancomprise six distinct anchor portions. In some embodiments, an increasednumber of distinct anchor portions can further decouple the orientationof a curved puncture portion from any rotation of the proximal portionof the puncture needle. In some embodiments, the number of distinctanchor portions can be selected to provide a desired stabilization inthe axial orientation of the curved puncture portion while providing alow profile puncture needle.

FIGS. 8A and 8B show a puncture needle system 800. The puncture needlesystem 800 can comprise the puncture needle 100 described with referenceto FIG. 3, and a delivery catheter 802 configured to receive thepuncture needle 100. Side cross-sectional views along a longitudinalaxis of the delivery catheter 802 are shown in FIGS. 8A and 8B. Thepuncture needle 100 can be pre-loaded into the delivery catheter 802.For example, the puncture needle 100 can be positioned within thedelivery catheter 802 prior to positioning the puncture needle system800 at a target location to access the target tissue site, such as priorto inserting the puncture needle system 800 into the patient. FIG. 8Ashows the puncture needle 100 pre-loaded in the delivery catheter 802and in a retracted state. FIG. 8B shows the puncture needle 100 in adeployed state. Referring to FIG. 8A, the delivery catheter 802 cancomprise a puncture needle lumen 804 configured to receive the punctureneedle 100. A distal portion 806 of the delivery catheter 802 cancomprise a side outlet opening 808 configured to allow extensiontherethrough of the puncture needle 100 to access the target tissuesite. In some embodiments, the delivery catheter 802 can comprise aguide wire lumen 810 configured to receive a guide wire (not shown). Thedelivery catheter 802 can be advanced along the guide wire so as toposition the delivery catheter 802 at a desired location to access thetarget tissue site.

Insertion of a puncture needle through one or more bends of tortuousanatomical pathways can result in undesired axial rotation of thepuncture needle. Undesired rotation of a puncture needle positionedwithin a delivery catheter can cause misalignment of the puncture needlerelative to the side outlet opening, thereby impeding desired deploymentof the puncture needle from the delivery catheter, and/or use of thepuncture needle to pierce tissue at the target tissue site. In someembodiments, misalignment of the puncture needle can hinder effectivepuncture of the tissue.

The anchor portion 170 can comprise a portion positioned within aportion of the puncture needle lumen 804 distal of the side outletopening 808. In the retracted state, the second bend 136 of the punctureneedle 100 can be distal of the side outlet opening 808. For example, aportion of the first anchor portion 130 and a portion of the secondanchor portion 140 can be received within the portion of the punctureneedle lumen 804 distal of the side outlet opening 808. In someembodiments, positioning a portion of the anchor portion 170 distal ofthe side outlet opening 808 can facilitate maintaining the desired axialorientation of the curved puncture portion 120 within the punctureneedle lumen 804. The anchor portion 170 can engage with the wall of theportion of the puncture needle lumen 804 distal of the side outletopening 808 to reduce or eliminate undesired rotation of the curvedpuncture portion 120 around a longitudinal axis of the puncture needle100.

In the retracted state, the first bend 126 of the puncture needle 100can be proximal of the side outlet opening 808. FIG. 8A shows thepuncture tip 180 proximal of the side outlet opening 808. In someembodiments, the entirety or substantially entirety of the curvedpuncture portion 120 can be proximal of the side outlet opening 808. Forexample, the puncture tip 180 and the curved puncture portion 120 can beproximal of the side outlet opening 808 and can be received within thepuncture needle lumen 804. The first bend 126 can be proximal of theside outlet opening 808. The anchor portion 170 can extend along thepuncture needle lumen 804 past the side outlet opening 808. For example,the anchor portion 170 can extend along a portion of the puncture needlelumen 804 proximal of the side outlet opening 808, through a portion ofthe lumen 804 at the side outlet opening 808, and along a portion of thepuncture needle lumen 804 distal of the side outlet opening 808.

In some embodiments, portions of the curved puncture portion 120 and/orthe anchor portion 170 can engage with a portion of the wall of thepuncture needle lumen 804 proximal of the side outlet opening 808. Thedistal portion 102 of the puncture needle 100 comprising the bends 126,136 can tend to exert radial force upon the curved puncture portion 120and the anchor portion 170 so as to provide a spring-loaded effect. Thetendency to extend radially can increase contact between the punctureneedle 100 and the lumen wall of the delivery catheter 802, therebyfacilitating fixation of the position and/or orientation of the curvedpuncture portion 120. In some embodiments, the tendency of the anchorportion 170 and curved puncture portion 120 to extend radially canfacilitate extension of the curved puncture portion 120 through the sideoutlet opening 808 when deploying the puncture needle 100. For example,when the curved puncture portion 120 is aligned with the side outletopening 808, the tendency to extend radially can facilitate extension ofthe curved puncture portion 120 beyond the opening 808 to assume itsdesired curved shape.

Referring to FIG. 8B, while the puncture needle 100 is in the deployedstate, at least a portion of the curved puncture portion 120 can beextended through the side outlet opening 808. In some embodiments, asshown in FIG. 8B, only a portion of the curved puncture portion 120 canbe extended through the side outlet opening 808 in the deployed state.For example, the first bend 126 can be within the puncture needle lumen804 proximal of the side outlet opening 808. In some embodiments, theentire or substantially the entire curved puncture portion 120 can beextended beyond the side outlet opening 808. For example, the first bend126 can be released from the puncture needle lumen 804. In someembodiments, the first bend 126 can be extended beyond the side outletopening 808 in the deployed state. In some embodiments, the first bend126 can be aligned with the side outlet opening 808.

The puncture needle 100 can be distally translated relative to thedelivery catheter 802 to release at least a portion of the curvedpuncture portion 120 through the side outlet opening 808. The punctureneedle 100 can be pushed to align the curved puncture portion 120 withthe side outlet opening 808 such that the puncture tip 180 and at leasta portion of the curved puncture portion 120 can be extended through theside outlet opening 808. The curved puncture portion 120 can comprise ashape memory material such that once the curved puncture portion 120 isfreed from the constraints of the delivery catheter 802, the curvedpuncture portion 120 can assume its desired curved configuration.

After the opening at the target tissue location is formed, the punctureneedle 100 can be translated proximally to retract the curved punctureportion 120 back into the puncture needle lumen 804 through the sideoutlet opening 808. For example, the puncture needle 100 can be pulledrelative to the delivery catheter 802 to retract the curved punctureportion 120 back into the lumen 804.

Alternatively, in some embodiments, while the puncture needle 100 is inthe retracted state, at least a portion of the curved puncture portion120 can be positioned within the portion of the puncture needle lumen804 distal of the side outlet opening 808. In some embodiments, in theretracted state, the curved puncture portion 120 can be entirely orsubstantially entirely distal of the side outlet opening 808. Thepuncture needle 100 can be translated proximally relative to thedelivery catheter 802 to release at least a portion of the curvedpuncture portion 120 through the side outlet opening 808. The punctureneedle 100 can be pulled to align the curved puncture portion 120 withthe side outlet opening 808 to extend the puncture tip 180 and at leasta portion of the curved puncture portion 120 through the side outletopening 808.

FIG. 9 shows a puncture needle system 900 comprising a delivery catheter902 and the puncture needle 100 received within the delivery catheter902. The delivery catheter 902 can comprise a puncture needle lumenconfigured to receive the puncture needle 100. A distal portion 906 ofthe delivery catheter 902 can comprise a side outlet opening 908configured to allow extension therethrough of the puncture needle 100.The distal portion 906 can comprise a curved portion, such as tofacilitate positioning of the distal portion 906 into a target vessel,channel, chamber and/or organ. In some embodiments, an expandable anchor910 can be associated with the distal portion 906 of the deliverycatheter 902. The expandable anchor 910 can assume an expanded state tofacilitate stably positioning the distal portion 906 at a desiredlocation within the target vessel, channel, chamber and/or organ. Forexample, the 910 can be associated with the curved portion of the distalportion 906. In some embodiments, the delivery catheter 902 can comprisea guide wire lumen extending therethrough and configured to receive adelivery catheter guide wire. The delivery catheter 902 can be advancedalong the delivery catheter guide wire so as to position the deliverycatheter 902 at a desired location to access the target tissue site.

The puncture needle system 900 can comprise a medical implant guide wiresheath 950 configured to receive a medical implant guide wire (notshown). The medical implant guide wire sheath 950 can comprise a distalportion 952 configured to be coupled to the curved puncture portion 120of the puncture needle 100. In some embodiments, the distal portion 952can be fixedly coupled to the curved puncture portion 120 such that thedistal portion 952 can be translated proximally and/or distally alongwith the curved puncture portion 120. The distal portion 952 of themedical implant guide wire sheath 950 can be extended and/or retractedthrough the side outlet opening 908 along with the curved punctureportion 120 of the puncture needle 100. In some embodiments, the medicalimplant guide wire sheath 950 can be coupled to a portion of the curvedpuncture portion 120. In some embodiments, the medical implant guidewire sheath 950 can be coupled to the entirety or substantially theentirety of the curved puncture portion 120. The medical implant guidewire sheath 950 can extend proximally from the curved puncture portion120, for example being received in the puncture needle lumen of thedelivery catheter 902.

The medical implant guide wire sheath 950 can comprise a distal end 954coupled to the curved puncture portion 120. The distal end 954 can beproximal of the first end 122 of the curved puncture portion 120. Forexample, the distal end 954 can be proximal of the puncture tip 180. Insome embodiments, the distal end 954 can be at the first end 122, forexample adjacent to the puncture tip 180. The medical implant guide wiresheath 950 can comprise a distal outlet opening 956 through which themedical implant guide wire can be extended. The distal outlet opening956 can be at or proximate to the distal end 954.

After the opening is formed at the target tissue site, the medicalimplant guide wire can be advanced through the medical implant guidewire sheath 950. A distal portion of the medical implant guide wire canbe extended through the distal outlet opening 956, and into the openingformed at the target tissue site. The puncture needle system 900,including the medical implant guide wire sheath 950, can be retractedafter the medical implant guide wire is positioned through the openingformed at the target tissue site, leaving the medical implant guide wirein place. A medical implant device can subsequently be advanced alongthe medical implant guide wire to the target tissue site. For example, ashunt device can be advanced along the medical implant guide wire to anopening formed on the left atrial wall to shunt blood flow from the leftatrium into the coronary sinus.

FIG. 10 shows an example of a puncture needle 1000 comprising a curvedanchor portion 1030 and a proximally or substantially proximallyoriented curved puncture portion 1020. A distal portion 1002 of thepuncture needle 1000 can comprise the curved puncture portion 1020 andthe curved anchor portion 1030. For example, the curved anchor portion1030 can comprise a pre-formed curvature. The puncture needle 1000 cancomprise an elongate portion 1010 and a distal portion 1012 of theelongate portion 1010 can comprise the curved puncture portion 1020 andthe curved anchor portion 1030. The curved anchor portion 1030 cancomprise a portion extending distally of the curved puncture portion1020. For example, a distal end 1032 of the curved anchor portion 1030can be distal of the curved puncture portion 1020. The curved anchorportion 1030 can comprise a second end 1034 coupled to the curvedpuncture portion 1020. The curved puncture portion 1020 can comprise afirst end 1022 associated with a puncture tip 1040 and a second end 1024coupled to the second end 1034 of the curved anchor portion 1030. Thecurved puncture portion 1020 can comprise one or more features of thecurved puncture portion 120 described with reference to FIG. 3. Forexample, the curved puncture portion 1020 can comprise a segment of acircle, such as a semi-circle. In some embodiments, the curved punctureportion 1020 can be oriented proximally. In some embodiments, thepuncture tip 1040 can point proximally. In some embodiments, thepuncture tip 1040 can point laterally.

The puncture needle 1000 can be received within a delivery catheter. Adistal portion of the delivery catheter can comprise a side outletopening through which the puncture needle 1000 can extend, such as thecurved puncture portion 1020. The portion of the curved anchor portion1030 extending distally of the curved puncture portion 1020 can beconfigured to engage with a portion of the delivery catheter lumendistal of the side outlet opening to reduce or eliminate axial rotationof the curved puncture portion 1020.

A curvature of the curved puncture portion 1020 and a curvature of thecurved anchor portion 1030 can have the same orientation. As shown inFIG. 10, both the curved puncture portion 1020 and the curved anchorportion 1030 can be proximally oriented. For example, an inner edge ofthe curvature of the curved anchor portion 1030 can comprise at least aportion which is proximally oriented.

In some embodiments, in a relaxed state, the curved puncture portion1020 can have a radius of curvature smaller than that the curved anchorportion 1030. For example, the degree of curvature of the curvedpuncture portion 1020 can be greater than that of the curved anchorportion 1030. The radius of curvature of the curved anchor portion 1030can be selected based on a curvature of the anatomical pathway adjacentto or proximate to the target tissue site. For example, as describedherein, the puncture needle 1000 can be configured to be inserted intothe coronary sinus to pierced tissue on a portion of the left atrialwall accessible from within the coronary sinus. The radius of curvatureof the curved anchor portion 1030 can be selected based on the radius ofcurvature of the coronary sinus into which the curved anchor portion1030 is advanced. For example, the curved anchor portion 1030 can beshaped to follow a length of the curvature of the coronary sinus.

In some embodiments, the curved puncture portion 1020 and the curvedanchor portion 1030 can be in the same plane and/or parallel planes. Forexample, the curved puncture portion 1020 and the curved anchor portion1030 can extend along lines which are in the same plane and/or parallelplanes. The curved puncture portion 1020 and the curved anchor portion1030 can comprise respective portions in the same plane. The respectiveportions of the curved puncture portion 1020 and the curved anchorportion 1030 can extend along lines contained in the same plane, suchthat the curved puncture portion 1020 and the curved anchor portion 1030each comprise portions which extend along lines contained in parallelplanes.

A lateral cross section of the curved puncture portion 1020 and thecurved anchor portion 1030 can comprise a non-circular shape, such as apolygonal shape, including a rectangular shape. Alternatively, thelateral cross section can comprise a rounded shape, including a circularshape. A lateral cross section of the curved puncture portion 1020 andthe curved anchor portion 1030 can be taken along a plane perpendicularor substantially perpendicular to a respective concavity of the curvedpuncture portion 1020 and curved anchor portion 1030.

In some embodiments, the curved puncture portion 1020 and the curvedanchor portion 1030 can be integrally formed. For example, the distalportion 1012 of the elongate portion 1010 can comprise a curved distalelongate portion and the curved puncture portion 1020 extending from thecurved distal elongate portion. The curved distal elongate portion canbe the curved anchor portion 1030. The curved puncture portion 1020 canextend from the second end 1034 of the curved distal elongate portion,and can extend to the puncture tip 1040.

FIG. 11 shows an example of a puncture needle 1100 comprising a curvedanchor portion 1130 and a distally or substantially distally orientedcurved puncture portion 1120. The curved anchor portion 1120 cancomprise a pre-formed curvature. An inner edge of a curvature of thecurved puncture portion 1120 can comprise at least a portion orienteddistally. For example, the concave portion of the curved punctureportion 1120 can comprise at least a portion which is oriented distally.The curved puncture portion 1120 can comprise one or more features ofthe curved puncture portion 520 described with reference to FIG. 7. Thecurved puncture portion 1120 can comprise a first end 1122 associatedwith a puncture tip 1140 and a second end 1124 coupled to the curvedanchor portion 1130. The curved anchor portion 1130 can comprise asecond end 1134 coupled to the curved puncture portion 1120. In someembodiments, the curved puncture portion 1120 can comprise a segment ofa circle, such as a semi-circle. In some embodiments, the puncture tip1140 can point distally. In some embodiments, the puncture tip 1140 canpoint laterally.

The puncture needle 1100 can comprise one or more other features of thepuncture needle 1000 described with reference to FIG. 10. For example, adistal portion 1102 of the puncture needle 1100 can comprise the curvedpuncture portion 1120 and the curved anchor portion 1130. The punctureneedle 1100 can comprise an elongate portion 1110 and a distal portion1112 of the elongate portion 1010 can comprise the curved punctureportion 1120 and the curved anchor portion 1130. The curved anchorportion 1130 can comprise a portion extending distally of the curvedpuncture portion 1120, including a distal end 1132 of the curved anchorportion 1130. The curved anchor portion 1130 can be proximally oriented.In some embodiments, a curved puncture portion 1120 can have a radius ofcurvature smaller than that the curved anchor portion 1130.

In some embodiments, the curved puncture portion 1120 and the anchorportion 1130 can comprise at least some portions in the same planeand/or parallel planes. For example, the curved puncture portion 1120and the curved anchor portion 1130 can extend along lines which are inthe same plane and/or parallel planes. The curved puncture portion 1120and the curved anchor portion 1130 can comprise respective portions inthe same plane. The respective portions of the curved puncture portion1120 and the curved anchor portion 1130 can extend along lines containedin the same plane, such that the curved puncture portion 1120 and thecurved anchor portion 1130 each comprise portions which extend alonglines contained in parallel planes. In some embodiments, a lateral crosssection of the curved puncture portion 1120 and the curved anchorportion 1130 can comprise a non-circular shape, such as a polygonalshape, including a rectangular shape. Alternatively, the lateral crosssection can comprise a rounded shape, including a circular shape. Insome embodiments, the curved puncture portion 1120 and the curved anchorportion 1130 can be integrally formed. For example, the distal portion1112 of the elongate portion 1110 can comprise a curved distal elongateportion and the curved puncture portion 1120 extending from the curveddistal elongate portion. The curved distal elongate portion can be thecurved anchor portion 1130.

FIG. 12 shows an example of a puncture needle 1200 comprising a distalportion 1202 which includes an anchor portion 1230 and a curved punctureportion 1220, where the anchor portion 1230 and the curved punctureportion 1220 are integrally formed. FIG. 12 is a plan view of thepuncture needle 1200 which shows the curved puncture portion 1220unfurled in a straight or substantially straight configuration. Thecurved puncture portion 1220 can comprise a shape memory material suchthat once the curved puncture portion 1220 is freed from the constraintsof a delivery catheter, the curved puncture portion 1220 can assume itsdesired curved configuration. The curved puncture portion 1220 cancomprise a first end 1222 associated with a puncture tip 1240, and asecond end 1224 which meets the anchor portion 1230. The curved punctureportion 1220 and the anchor portion 1230 can be formed and/or derivedfrom a single piece of material 1210. A distal portion 1212 of the pieceof material 1210 can be split into two portions to provide the anchorportion 1230 and the curved puncture portion 1220. For example, thecurved puncture portion 1220 can be cut and/or carved from the distalportion 1212 of the piece of material 1210. The curved puncture portion1220 can be cut and/or carved from the piece of material 1210 such thatthe curved puncture portion 1220 can be released from a remainingportion of the piece of material 1210. The remaining portion of thepiece of material 1210 can comprise the anchor portion 1230, for exampleextending from a position 1234 to a distal end 1232 on the distalportion 1212. In some embodiments, the curved puncture portion 1220 canbe laser cut from the piece of material 1210. The released curvedpuncture portion 1220 can extend from the position 1234 on the distalportion 1212 of the piece of material 1210 to the first end 1222associated with the puncture tip 1240. A surface region 1250 of thematerial 1210 from which the curved puncture portion 1220 is released isshown in FIG. 12. The surface region 1250 can be on the anchor portion1230. The anchor portion 1230 can comprise a portion extending distallyof the curved puncture portion 1220, including the distal end 1232 ofthe anchor portion 1230. For example, the portion extending distally ofthe curved puncture portion 1220 can comprise the surface region 1250thereon.

The curved puncture portion 1220 and the anchor portion 1230 cancomprise one or more features of the curved puncture portions and anchorportions as described herein. In some embodiments, the anchor portion1230 can be a curved anchor portion. In some embodiments, the anchorportion 1230 can comprise a pre-formed curvature. In some embodiments,both the anchor portion 1230 and the curved puncture portion 1220 can beproximally oriented. In some embodiments, the curved puncture portion1220 can have a radius of curvature smaller than that of the curvedanchor portion. In some embodiments, the anchor portion 1230 can belinear or substantially linear. The linear or substantially linearanchor portion can be flexible so as to conform to one or morecurvatures of a vessel, channel, chamber and/or organ into which thepuncture needle 1200 is positioned.

In some embodiments, the curved puncture portion 1220 and the anchorportion 1230 can comprise at least some portions in the same planeand/or parallel planes, for example portions extending along lines whichare in the same plane and/or parallel planes. In some embodiments, thecurved puncture portion 1220 and the anchor portion 1230 can comprisecorresponding portions in the same plane. For example, the curvedpuncture portion 1220 and the anchor portion 1230 can lay flat orsubstantially flat when laid on a side. Respective portions of thecurved puncture portion 1220 and the anchor portion 1230 can extendalong lines contained in the same plane, such that the curved punctureportion 1220 and the anchor portion 1230 each comprise respectiveportions which extend along lines contained in parallel planes.

FIGS. 13A and 13B show a puncture needle system 1300. The punctureneedle system 1300 can comprise the puncture needle 1000 described withreference to FIG. 10, and a delivery catheter 1302 configured to receivethe puncture needle 1000. Side cross-sectional views along alongitudinal axis of the delivery catheter 1302 are shown in FIGS. 13Aand 13B. FIG. 13A shows the puncture needle 1000 pre-loaded in thedelivery catheter 1302 and in a retracted state. FIG. 13B shows thepuncture needle 1000 in a deployed state. Referring to FIG. 13A, thedelivery catheter 1302 can comprise a puncture needle lumen 1304configured to receive the puncture needle 1000. A distal portion 1306 ofthe delivery catheter 1302 can comprise a side outlet opening 1308. Thepuncture needle 1000 can be extended through the side outlet opening1308 to access the target tissue site.

The delivery catheter 1302 can comprise a guide wire lumen 1310extending along a length, such as an entire length, of the deliverycatheter 1302, and configured to receive a delivery catheter guide wire(not shown). The delivery catheter 1302 can be advanced along thedelivery catheter guide wire into a vessel, channel, chamber, and/ororgan to position the side outlet opening 1308 at or proximate to thetarget tissue site. In some embodiments, after the delivery catheter isadvanced along the delivery catheter guide wire to the desired locationwithin the vessel, channel, chamber, and/or organ, the delivery catheterguide wire can be retracted, leaving the delivery catheter at thedesired location.

The anchor portion 1030 can comprise a portion configured to bepositioned within a portion of the puncture needle lumen 1304 distal ofthe side outlet opening 1308, both in the retracted state and in thedeployed state. For example, the distal end 1032 of the anchor portion1030 can remain in the portion of the puncture needle lumen 1304 distalof the side outlet opening 1308. The portion of the anchor portion 1030distal of the side outlet opening 1308 can engage with the wall of theportion of the puncture needle lumen 1304 distal of the side outletopening 1308 to reduce or eliminate undesired rotation of the curvedpuncture portion 1020 around a longitudinal axis of the puncture needle1000.

Referring to FIG. 13A, in the retracted state, the curved punctureportion 1020 can remain or substantially remain within the punctureneedle lumen 1304. The second end 1024 of the curved puncture portion1020 can be proximal of the side outlet opening 1308. FIG. 13A shows thepuncture tip 1040 proximal of the side outlet opening 1308. In someembodiments, the entirety or substantially entirety of the curvedpuncture portion 1020 can be proximal of the side outlet opening 1308.For example, the puncture tip 1040 and the curved puncture portion 1020can be proximal of the side outlet opening 1308 and can be receivedwithin the puncture needle lumen 1304. The second end 1024 of the curvedpuncture portion 1020 and the second end 1034 of the anchor portion 1030can be proximal of the side outlet opening 1308. The anchor portion 1030can extend along the puncture needle lumen 1304 past the side outletopening 1308. For example, the anchor portion 1030 can extend along aportion of the puncture needle lumen 1304 proximal of the side outletopening 1308, through a portion of the lumen 1304 at the side outletopening 1308, and along a portion of the puncture needle lumen 1304distal of the side outlet opening 1308.

In some embodiments, both the curved puncture portion 1020 and theanchor portion 1030 can engage with corresponding portions of thedelivery catheter lumen wall to prevent or reduce axial rotation of thecurved puncture portion 1020. For example, the curved puncture portion1020 and the anchor portion 1030 can have a tendency to extend radially.For example, the curved puncture portion 1020 and the anchor portion1030 can be spring-loaded. The tendency to extend radially can increasecontact between the puncture needle 1000 and the lumen wall of thedelivery catheter 1302, facilitating fixation of the position and/ororientation of the curved puncture portion 1020. In some embodiments,the tendency of the anchor portion 1030 and curved puncture portion 1020to extend radially can facilitate extension of the curved punctureportion 1020 through the side outlet opening 1308 when deploying thepuncture needle 1000.

Referring to FIG. 13B, in the deployed state, at least a portion of thecurved puncture portion 1020 can be extended through the side outletopening 1308. In some embodiments, only a portion of the curved punctureportion 1020 is extended through the side outlet opening. For example,the second end 1024 can be within the lumen 1304 and proximal of theside outlet opening 1308. Alternatively, the entire or substantially theentire curved puncture portion 1020 can be extended beyond the sideoutlet opening 1308. For example, the second end 1024 of the curvedpuncture portion 1020 and the second end 1034 of the anchor portion 1030can be aligned with the side outlet opening 1308. The entire curvedpuncture portion 1020 and the puncture tip 1040 can be extended throughthe side outlet opening 1308.

The puncture needle 1000 can be distally translated relative to thedelivery catheter 1302 to release at least a portion of the curvedpuncture portion 1020 through the side outlet opening 1308, such asreleasing the entire or substantially the entire curved puncture portion1020. The curved puncture portion 1020 can comprise a shape memorymaterial such that as the curved puncture portion 1020 is aligned withthe side outlet opening 1308, the curved puncture portion 1020 canextend through the side outlet opening 1308 and assume its desiredcurved configuration. The puncture needle 1000 can be translatedproximally to retract the curved puncture portion 1020 back into thepuncture needle lumen 1304 through the side outlet opening 1308, afterthe opening at the target tissue location is formed. For example, thepuncture needle 1000 can be pulled to retract the curved punctureportion 1020 back into the lumen 1304.

Alternatively, in some embodiments, while the puncture needle 1000 is inthe retracted state, at least a portion of the curved puncture portion1020 can be positioned within the portion of the puncture needle lumen1304 distal of the side outlet opening 1308. For example, the puncturetip 1040 can be distal of the side outlet opening 1308. In someembodiments, in the retracted state, the curved puncture portion 1020can be entirely or substantially entirely distal of the side outletopening 1308. The puncture needle 1000 can be translated proximallyrelative to the delivery catheter 1302 to release at least a portion ofthe curved puncture portion 1020 through the side outlet opening 1308.The puncture needle 1000 can be pulled to align the curved punctureportion 1020 with the side outlet opening 1308 such that the puncturetip 1040 and at least a portion of the curved puncture portion 1020 canbe extended through the side outlet opening 1308.

FIGS. 14A through 14D show an example of a puncture needle system 1400comprising a delivery catheter 1402 and a puncture needle 1500. Thedelivery catheter 1402 can comprise a puncture needle lumen 1404configured to receive the puncture needle 1500. A distal portion 1406 ofthe delivery catheter 1402 can comprise a side outlet opening 1408configured to allow extension therethrough of a portion of the punctureneedle 1500 for accessing and forming an opening at the target tissuesite. The delivery catheter 1402 can comprise a guide wire lumen 1410configured to receive a delivery catheter guide wire (not shown). Forexample, the guide wire lumen 1410 can extend along a length, such as anentire length, of the delivery catheter 1402 such that the deliverycatheter 1402 can be advanced along the delivery catheter guide wireinto the desired vessel, channel, chamber, and/or organ. In someembodiments, the delivery catheter guide wire can be withdrawn after thedelivery catheter 1402 is positioned at the target location, leaving thedelivery catheter 1402 in place.

FIG. 14A shows a distal portion 1502 of the puncture needle 1500. Thedistal portion 1502 can comprise a curved puncture portion 1520 coupledto an anchor portion 1530. For example, a distal portion 1512 of anelongate portion 1510 of the puncture needle 1500 can comprise thecurved puncture portion 1520 extending from the anchor portion 1530. Theanchor portion 1530 can comprise a distal end 1532, and a second end1534 coupled to the curved puncture portion 1520. The curved punctureportion 1520 can comprise a first end 1522 associated with a puncturetip 1540 and a second end 1524 coupled to the second end 1534 of theanchor portion 1530. The anchor portion 1530 can comprise a portionextending distally of the curved puncture portion 1520, including forexample the distal end 1532 of the anchor portion 1530.

In some embodiments, the anchor portion 1530 can assume a linear orsubstantially linear configuration in a relaxed state. The anchorportion 1530 can be flexible. For example, the anchor portion 1530 canbend to assume a curved configuration. The anchor portion 1530 canassume the curved configuration while received within the deliverycatheter 1402. For example, the anchor portion 1530 can assume thecurved configuration while the delivery catheter 1402 is advancedthrough a tortuous anatomical pathway to a desired location to accessthe target tissue site and/or while the delivery catheter 1402 ispositioned at or proximate to the desired location. A radius ofcurvature of the anchor portion 1530 in the curved configuration can bebased on a curvature of the anatomical pathway adjacent to or proximateto the target tissue site, such as a length of the coronary sinusadjacent to or proximate to the target tissue site on the left atrialwall. A radius of curvature of the curved puncture portion 1520 can beselected to facilitate effective piercing of the tissue while thepuncture needle 1500 is positioned at a desired location to access thetarget tissue site. For example, the radius of curvature can bepredetermined to enable desired insertion of the curved puncture portion1520 through the target tissue as the puncture needle 1500 is extendedfrom the side outlet opening 1408. In some embodiments, the radius ofcurvature of the anchor portion 1530 in the curved configuration whilepositioned at or proximate to the target tissue site is larger than thatof the curved puncture portion 1520, the degree of curvature of thecurved puncture portion 1520 being larger than that of the anchorportion 1530. The curvature of the curved puncture portion 1520 and thatof the anchor portion 1530 in the curved configuration while positionedat or proximate to the target tissue site can have the same orientation,such as being proximally oriented. In some embodiments the puncture tip1540 can be laterally pointed. In some embodiments, the puncture tip1540 can be proximally pointed.

As shown in FIG. 14A, a lateral cross section of the anchor portion 1530can have a non-circular shape, such as a polygonal shape. The lateralcross section can be taken along a plane perpendicular or substantiallyperpendicular to a longitudinal axis of the puncture needle 1500. Insome embodiments, the lateral cross section of the anchor portion 1530can be rectangular or substantially rectangular. In some embodiments,the lateral cross-sectional shape can be selected to interlock with alateral cross-sectional shape of the delivery catheter lumen 1404 suchthat the anchor portion 1530 does not or substantially does not axiallyrotate within the lumen 1404, thereby reducing or eliminating axialrotation of the curved puncture portion 1520. The anchor portion 1530can comprise at least a portion which extends distally of the sideoutlet opening 1408 while the puncture needle 1500 is both a retractedstate and a deployed state. For example, the lateral cross-sectionalshape of the lumen 1404 distal of the side outlet opening 1408 can benon-circular so as to interlock with the anchor portion 1530.

In some embodiments, a lateral cross section of the curved punctureportion 1520 can be non-circular. The lateral cross section can be takenalong a plane perpendicular to the concavity of the curved punctureportion 1520. The lateral cross section can be selected to reduce aprofile of the curved puncture portion 1520, thereby facilitating areduced profile of the puncture needle 1500. In some embodiments, thelateral cross section can comprise a polygonal shape, including arectangular or substantially rectangular shape. The concavity of thecurved puncture portion 1520 can generally be normal to the long flatsurface of the rectangular-cross-sectional form thereof, as in FIG. 14A.

In some embodiments, the curved puncture portion 1520 and the anchorportion 1530 can be in the same plane and/or parallel planes, forexample extending along lines which are in the same plane and/orparallel planes. In some embodiments, the curved puncture portion 1520and the anchor portion 1530 can be in the same plane. For example, thecurved puncture portion 1520 and the anchor portion 1530 can lay flat orsubstantially flat when laid on a side. In some embodiments, respectiveportions of the curved puncture portion 1520, the anchor portion 1530can extend along lines contained in the same plane, such that the curvedpuncture portion 1520 and the anchor portion 1530 each comprise portionswhich extend along lines contained in parallel planes. In someembodiments, the curved puncture portion 1520 and the anchor portion1530 can be integrally formed, for example being a part of a singleelongate portion. For example, the distal portion 1512 of the elongateportion 1510 can comprise the curved puncture portion 1520 and theanchor portion 1530.

FIG. 14B is a lateral cross-sectional view of a portion of the deliverycatheter 1402 distal of the side outlet opening 1408. The lateral crosssection can be taken along a plane perpendicular or substantiallyperpendicular to a longitudinal axis of the delivery catheter 1402. Theguide wire lumen 1410 and the puncture needle lumen 1404 are shown. Theguide wire lumen 1410 can comprise a rounded shape, such as a circularor substantially circular shape. The lateral cross section of thepuncture needle lumen 1404 distal of the side outlet opening 1408 cancomprise a rectangular or substantially rectangular shape.

FIG. 14C is a perspective view of the portion of the delivery catheter1402 comprising the side outlet opening 1408. The puncture needle system1400 is shown with the puncture needle 1500 in a retracted state. Theanchor portion 1530 is shown as extending within the puncture needlelumen 1404 past the side outlet opening 1408. The second end 1524 of thecurved puncture portion 1520 and the second end 1534 of the anchorportion 1530 can be proximal of the side outlet opening 1408. The anchorportion 1530 can extend along a portion of the puncture needle lumen1404 proximal of the side outlet opening 1408, through a portion of thelumen 1404 at the side outlet opening 1408, and along a portion of thepuncture needle lumen 1404 distal of the side outlet opening 1408. Theanchor portion 1530 can extend through a portion of the puncture needlelumen 1404 distal of the side outlet opening 1408. The curved punctureportion 1520 can be entirely or substantially entirely within a portionof the puncture needle lumen 1404 proximal of the side outlet opening1408. For example, the puncture tip 1540 can be within the lumen 1404and proximal of the side outlet opening 1408. The puncture needle 1500can be translated distally, such as pushed, to release the curvedpuncture portion 1520 through the side outlet opening 1408 so as todeploy the curved puncture portion 1520. In some embodiments, thepuncture tip 1540 can be within the lumen 1404 and distal of the sideoutlet opening 1408. The puncture needle 1500 can be translatedproximally, such as pulled, to release the curved puncture portion 1520through the side outlet opening 1408. The curved puncture portion 1520can comprise a shape memory material such that once the curved punctureportion 1520 is freed from the constraints of the delivery catheter1402, the curved puncture portion 1520 can assume its desired curvedconfiguration.

FIG. 14D shows the puncture needle system 1400 in a deployed state. Thecurved puncture portion 1520 is shown as being extended through the sideoutlet opening 1408. In some embodiments, the curved puncture portion1520 can be partially extended through the side outlet opening 1408. Forexample, the second end 1524 of the curved puncture portion 1520 and thesecond end 1534 of the anchor portion 1530 can be proximal of the sideoutlet opening 1408. As the second end 1534 is within the deliverycatheter lumen 1404 and proximal of the side outlet opening 1408, thesecond end 1534 is not shown in FIG. 14D. In some embodiments, theentire or substantially the entire curved puncture portion 1520 isextended through the side outlet opening. For example, the second end1524 of the curved puncture portion 1520 and the second end 1534 of theanchor portion 1530 can be aligned with the side outlet opening 1408. Asdescribed herein, while the puncture needle 1500 is in the deployedstate, the anchor portion 1530 can comprise at least a portion whichextends distally of the side outlet opening 1408. In FIG. 14D, theanchor portion 1530 is shown as extending through the lumen 1404 pastthe side outlet opening 1408.

FIG. 15 is a flow diagram of an example of a process 1600 to deploy apuncture needle system for piercing tissue at a target tissue site. Thepuncture needle system can comprise features of one or more of thepuncture needle systems as described herein. At block 1602, theprocedure/process 1600 involves advancing the puncture needle systeminto a vessel. For example, the vessel can be a coronary sinus. Thepuncture needle system can be advanced into the coronary sinus via thecoronary sinus ostium from the right atrium. A transjugular ortrans-subclavian approach can be used to access the right atrium via thesuperior vena cava. Alternatively, a transfemoral approach can be usedto position the puncture needle system into the inferior vena cava, andfrom the inferior vena cava into the right atrium. The procedure/process1600 can comprise a minimally invasive transcatheter approach.

In some embodiments, the puncture needle system can be delivered intothe coronary sinus to access a left atrial wall from within the coronarysinus. The puncture needle system can be used to access a target tissuesite on the left atrial wall. The puncture needle system can be used toform an opening on the left atrial wall for delivery of one or moremedical therapies and/or implant devices. For example, the opening canbe formed on the left atrial wall for implantation of a shunt devicetherein, such as to provide an artificial blood flow conduit foralleviating elevated left atrial pressure.

The puncture needle system can comprise a puncture needle. The punctureneedle can comprise one or more features of the puncture needles asdescribed herein. For example, the puncture needle can comprise ananchor portion and a curved puncture portion. The puncture portion cancomprise a first end associated with a puncture tip and a second endcoupled to the anchor portion. The anchor portion can comprise a portiondistal of the curved puncture portion. The puncture needle system cancomprise a delivery catheter configured to receive the puncture needle.The delivery catheter can comprise a puncture needle lumen, and thepuncture needle can be extended slidably through the puncture needlelumen. A side outlet opening can be on a distal portion of the deliverycatheter such that at least a portion of the curved puncture portion canbe extended therethrough.

As described herein, the puncture needle can be pre-loaded. For example,prior to positioning the delivery catheter at the target tissue site,such as prior to insertion of the delivery catheter into the patient,the puncture needle can be at a desired position within the deliverycatheter. For example, a distal portion of the puncture needle can be ator proximate to the side outlet opening while the delivery catheter isadvanced to the target tissue site. The puncture needle can be in aretracted state within the delivery catheter as the delivery catheter isadvanced to the target tissue site. In some embodiments, while thepuncture needle is in the retracted state, at least a portion of theanchor portion is positioned within a portion of the puncture needlelumen distal of the side outlet opening. In some embodiments,interaction between the anchor portion and the portion of the punctureneedle lumen wall distal of the side outlet opening can facilitatemaintaining an axial orientation of the curved puncture portion relativeto the delivery catheter, regardless of any axial rotations of anyportions of the puncture needle proximal of the curved puncture portion.

In some embodiments, while the puncture needle is in the retractedstate, the curved puncture portion can be positioned proximal of theside outlet opening. In some embodiments, at least a portion of thecurved puncture portion can be positioned distal of the side outletopening while the puncture needle is in the retracted state. Forexample, a portion of the curved puncture portion and the puncture tipcan be within a portion of the puncture needle lumen distal of the sideoutlet opening. In some embodiments, the puncture tip can be within theside outlet opening and the curved puncture portion can comprise atleast a portion positioned within a portion of the puncture needle lumenproximal of the side outlet opening.

At block 1604, the procedure/process 1600 involves one of distally orproximally translating the puncture needle relative to the deliverycatheter to release at least a portion of the curved puncture portionthrough the side outlet opening. The puncture needle can be pushed orpulled to align the curved puncture portion with the side outlet openingsuch that the puncture tip and at least a portion of the curved punctureportion can be extended through the side outlet opening. For example, apuncture needle comprising a puncture tip distal of the side outletopening in the retracted state can be translated proximally relative tothe delivery catheter to release at least a portion of the curvedpuncture portion through the side outlet opening. A puncture needlecomprising a puncture tip proximal of the side outlet opening in theretracted state can be translated distally relative to the deliverycatheter to release at least a portion of the curved puncture portionthrough the side outlet opening. In some embodiments, the curvedpuncture portion can comprise a shape memory material such that once atleast a portion of the curved puncture portion is freed from theconstraints of the delivery catheter, the curved puncture portion cantend to assume its desired curved configuration.

At block 1606, the procedure/process 1600 involves extending at least aportion of the curved puncture portion through the side outlet opening.In a deployed state, the puncture needle can comprise the entirety orsubstantially the entirety of the curved puncture portion extendedbeyond the side outlet opening. In some embodiments, only a portion ofthe curved puncture portion is extended beyond the side outlet openingwhile the puncture needle is in a deployed state. As described herein,the curved puncture portion can comprise a pre-formed curvatureconfigured to facilitate accessing the target tissue site while thepuncture needle system is positioned in the vessel so as to facilitateeffective puncture of the target tissue site. For example, thepre-formed curvature of the curved puncture portion can have a radius ofcurvature to facilitate accessing and/or puncturing the target tissuesite on the left atrial wall while the curved puncture portion isextended from the delivery catheter positioned in the coronary sinus.

At block 1608, the procedure/process 1600 involves piercing tissue atthe target tissue site to form an opening at the target tissue siteusing the puncture tip of the puncture needle which has been extendedthrough the side outlet opening.

In some embodiments, the puncture needle system can comprise a medicalimplant guide wire sheath configured to slidably receive a medicalimplant guide wire. The medical implant guide wire sheath can comprise adistal portion coupled to at least a portion of the curved punctureportion. The medical implant guide wire can be advanced within themedical implant guide wire sheath to the target tissue site. The medicalimplant guide wire can be advanced through an opening associated with adistal end of the medical implant guide wire sheath into the openingformed at the target tissue site. After the medical implant guide wireis positioned at its target position, the medical implant guide wiresheath can be retracted, leaving the medical implant guide wire inplace. A medical implant device, such as a shunt device, can then beadvanced along the medical implant guide wire to a target implantationsite. For example, the shunt device can be advanced along the medicalimplant guide wire into the opening formed on the left atrial wall.

ADDITIONAL EMBODIMENTS

Depending on the embodiment, certain acts, events, or functions of anyof the processes or algorithms described herein can be performed in adifferent sequence, may be added, merged, or left out altogether. Thus,in certain embodiments, not all described acts or events are necessaryfor the practice of the processes.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isintended in its ordinary sense and is generally intended to convey thatcertain embodiments include, while other embodiments do not include,certain features, elements and/or steps. Thus, such conditional languageis not generally intended to imply that features, elements and/or stepsare in any way required for one or more embodiments or that one or moreembodiments necessarily include logic for deciding, with or withoutauthor input or prompting, whether these features, elements and/or stepsare included or are to be performed in any particular embodiment. Theterms “comprising,” “including,” “having,” and the like are synonymous,are used in their ordinary sense, and are used inclusively, in anopen-ended fashion, and do not exclude additional elements, features,acts, operations, and so forth. Also, the term “or” is used in itsinclusive sense (and not in its exclusive sense) so that when used, forexample, to connect a list of elements, the term “or” means one, some,or all of the elements in the list. Conjunctive language such as thephrase “at least one of X, Y and Z,” unless specifically statedotherwise, is understood with the context as used in general to conveythat an item, term, element, etc. may be either X, Y or Z. Thus, suchconjunctive language is not generally intended to imply that certainembodiments require at least one of X, at least one of Y and at leastone of Z to each be present.

It should be appreciated that in the above description of embodiments,various features are sometimes grouped together in a single embodiment,Figure, or description thereof for the purpose of streamlining thedisclosure and aiding in the understanding of one or more of the variousinventive aspects. This method of disclosure, however, is not to beinterpreted as reflecting an intention that any claim require morefeatures than are expressly recited in that claim. Moreover, anycomponents, features, or steps illustrated and/or described in aparticular embodiment herein can be applied to or used with any otherembodiment(s). Further, no component, feature, step, or group ofcomponents, features, or steps are necessary or indispensable for eachembodiment. Thus, it is intended that the scope of the inventions hereindisclosed and claimed below should not be limited by the particularembodiments described above, but should be determined only by a fairreading of the claims that follow.

It should be understood that certain ordinal terms (e.g., “first” or“second”) may be provided for ease of reference and do not necessarilyimply physical characteristics or ordering. Therefore, as used herein,an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modifyan element, such as a structure, a component, an operation, etc., doesnot necessarily indicate priority or order of the element with respectto any other element, but rather may generally distinguish the elementfrom another element having a similar or identical name (but for use ofthe ordinal term). In addition, as used herein, indefinite articles (“a”and “an”) may indicate “one or more” rather than “one.” Further, anoperation performed “based on” a condition or event may also beperformed based on one or more other conditions or events not explicitlyrecited.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which example embodiments belong. It befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art and notbe interpreted in an idealized or overly formal sense unless expresslyso defined herein.

The spatially relative terms “outer,” “inner,” “upper,” “lower,”“below,” “above,” “vertical,” “horizontal,” and similar terms, may beused herein for ease of description to describe the relations betweenone element or component and another element or component as illustratedin the drawings. It be understood that the spatially relative terms areintended to encompass different orientations of the device in use oroperation, in addition to the orientation depicted in the drawings. Forexample, in the case where a device shown in the drawing is turned over,the device positioned “below” or “beneath” another device may be placed“above” another device. Accordingly, the illustrative term “below” mayinclude both the lower and upper positions. The device may also beoriented in the other direction, and thus the spatially relative termsmay be interpreted differently depending on the orientations.

Unless otherwise expressly stated, comparative and/or quantitativeterms, such as “less,” “more,” “greater,” and the like, are intended toencompass the concepts of equality. For example, “less” can mean notonly “less” in the strictest mathematical sense, but also, “less than orequal to.”

What is claimed is:
 1. A puncture needle comprising: a puncture tipconfigured to pierce tissue; and an elongate portion, wherein theelongate portion comprises a distal portion comprising: a curvedpuncture portion having a first end associated with the puncture tip,and extending from the first end to a first bend having a first acuteangle oriented distally; a first distal elongate portion, the firstdistal elongate portion meeting the curved puncture portion at the firstbend, and the first distal elongate portion extending from the firstbend to a second bend having a second acute angle oriented proximally;and a second distal elongate portion, the first distal elongate portionand the second distal elongate portion meeting at the second bend, andthe second distal elongate portion extending proximally from the secondbend, wherein the second bend is distal of the curved puncture portion.2. The puncture needle of claim 1, wherein the first distal elongateportion, the second distal elongate portion and the curved punctureportion are in one plane.
 3. The puncture needle of claim 1, wherein theelongate portion is a single wire.
 4. The puncture needle of claim 1,wherein the first distal elongate portion comprises a first distalcurved portion and the second distal elongate portion comprises a seconddistal curved portion, the first distal curved portion and the seconddistal curved portion having a same orientation as the curved punctureportion.
 5. The puncture needle of claim 4, wherein a radius ofcurvature the curved puncture portion is smaller than that of each ofthe first distal curved portion and the second distal curved portion. 6.A puncture needle comprising: a puncture tip configured to piercetissue; and an elongate portion comprising a distal portion, the distalportion comprising a curved distal elongate portion and a curvedpuncture portion extending from the curved distal elongate portion tothe puncture tip, wherein the curved distal elongate portion and thecurved puncture portion have a same orientation, and wherein a distalend of the curved distal elongate portion is distal of the curvedpuncture portion.
 7. The puncture needle of claim 6, wherein a radius ofcurvature of the curved distal elongate portion is greater than that ofthe curved puncture portion.
 8. A puncture needle comprising: a puncturetip configured to pierce tissue; and a distal portion comprising: ananchor portion; and a curved puncture portion comprising a first endassociated with the puncture tip and a second end coupled to the anchorportion, wherein the anchor portion comprises a portion distal of thecurved puncture portion.
 9. The puncture needle of claim 8, wherein thecurved puncture portion is proximally oriented, and wherein the puncturetip points proximally.
 10. The puncture needle of claim 8, wherein thecurved puncture portion is distally oriented, and wherein the puncturetip points distally.
 11. The puncture needle of claim 8, wherein thecurved puncture portion comprises a segment of a circle.
 12. Thepuncture needle of claim 11, wherein the curved puncture portioncomprises a semi-circle.
 13. The puncture needle of claim 8, wherein thedistal portion comprises a lateral cross-section having a rectangularshape, the lateral cross-section being taken along a plane perpendicularto a longitudinal axis of the puncture needle.
 14. The puncture needleof claim 8, wherein the anchor portion is a curved anchor portion, thecurved anchor portion comprising the portion distal of the curvedpuncture portion, and a proximal portion coupled to the second end ofthe curved puncture portion.
 15. The puncture needle of claim 14,wherein the curved anchor portion and the curved puncture portioncomprise a same orientation.
 16. The puncture needle of claim 14,wherein a radius of curvature of the curved puncture portion is smallerthan that of the curved anchor portion.
 17. The puncture needle of claim14, wherein the curved anchor portion comprises a shape configured toconform to a curvature along a length of a coronary sinus.
 18. Thepuncture needle of claim 8, wherein the anchor portion comprises: afirst anchor portion comprising a first end and a second end, whereinthe first end of the first anchor portion is coupled to the curvedpuncture portion; and a second anchor portion comprising a first endcoupled to the second end of the first anchor portion, and wherein thesecond anchor portion extends proximally from the first end of thesecond anchor portion, wherein the first anchor portion and the secondanchor portion meet at a bend, the bend is proximally oriented, and thebend is distal of the curved puncture portion.
 19. The puncture needleof claim 18, wherein the bend comprises an acute angle.
 20. The punctureneedle of claim 18, wherein the curved puncture portion, the firstanchor portion, and the second anchor portion are in one plane.
 21. Thepuncture needle of claim 18, wherein the first anchor portion is a firstcurved anchor portion and the second anchor portion is a second curvedanchor portion.
 22. The puncture needle of claim 21, wherein the curvedpuncture portion, the first curved anchor portion, and the second curvedanchor portion comprise a same orientation.
 23. The puncture needle ofclaim 21, wherein a radius of curvature of the curved puncture portionis smaller than that of each of the first curved anchor portion and thesecond curved anchor portion.
 24. The puncture needle of claim 21,wherein the first curved anchor portion and second curved anchor portioneach comprise a shape configured to conform to a curvature along alength of a coronary sinus.
 25. The puncture needle of claim 18, whereinthe first anchor portion and the second anchor portion are each linearportions.
 26. The puncture needle of claim 25, wherein the curvedpuncture portion is proximally oriented, wherein the curved punctureportion and the first end of the first anchor portion meet at a distallyoriented first bend, wherein the first anchor portion and the secondanchor portion meet at a proximally oriented second bend.
 27. A punctureneedle system, comprising: a puncture needle comprising a puncture tipand a distal portion, the distal portion comprising: an anchor portion,and a curved puncture portion comprising a first end associated with thepuncture tip and a second end coupled to the anchor portion, the anchorportion comprising a portion distal of the curved puncture portion; anda delivery catheter comprising a lumen, the puncture needle extendingthrough the lumen, and a side outlet opening on a distal portion of thedelivery catheter configured to allow extension therethrough of at leasta portion of the curved puncture portion, wherein the anchor portionextends through a distal portion of the lumen distal of the side outletopening.
 28. The system of claim 27, wherein the distal portion of thelumen distal of the side outlet opening comprises a lateral crosssection comprising a non-circular shape, the lateral cross section beingtaken along a plane perpendicular to a longitudinal axis of the deliverycatheter.
 29. The system of claim 28, wherein the lateral cross-sectionof the distal portion of the lumen comprises a same shape as a lateralcross section of the anchor portion.
 30. The system of claim 27, andfurther comprising a medical implant guide wire sheath configured toslidably receive a medical implant guide wire, the medical implant guidewire sheath comprising a distal portion coupled to at least a portion ofthe curved puncture portion.
 31. The system of claim 27, wherein theanchor portion is a curved anchor portion, the curved anchor portioncomprising the portion distal of the curved puncture portion, and aproximal portion coupled to the second end of the curved punctureportion.
 32. The system of claim 27, wherein the anchor portioncomprises: a first anchor portion comprising a first end and a secondend, wherein the first end of the first anchor portion is coupled to thecurved puncture portion; and a second anchor portion comprising a firstend coupled to the second end of the first anchor portion, and whereinthe second anchor portion extends proximally from the first end of thesecond anchor portion, wherein the first anchor portion and the secondanchor portion meet at a bend, the bend is proximally oriented, and thebend is distal of the curved puncture portion.
 33. The system claim 32,wherein the curved puncture portion, the first anchor portion, and thesecond anchor portion are in one plane.
 34. The system of claim 32,wherein the first anchor portion is a first curved anchor portion andthe second anchor portion is a second curved anchor portion, wherein thecurved puncture portion, the first curved anchor portion, and the secondcurved anchor portion comprise a same orientation.
 35. The system ofclaim 32, wherein the first anchor portion and the second anchor portionare each linear portions.
 36. The system of claim 27, wherein, while thepuncture needle is in a retracted state, the puncture tip is configuredto be proximal of the side outlet opening and the anchor portioncomprises a portion extending along the lumen past the side outletopening and through the portion of the lumen distal of the side outletopening.
 37. The system of claim 27, wherein, while the puncture needleis in a retracted state, the puncture tip is configured to be distal ofthe side outlet opening and the anchor portion extends distally throughthe portion of the lumen distal of the side outlet opening.
 38. A methodfor delivering a puncture needle, comprising: advancing a punctureneedle system into a vessel, the puncture needle system comprising: apuncture needle comprising a distal portion, the distal portioncomprising: an anchor portion, and a curved puncture portion comprisinga first end associated with a puncture tip and a second end coupled tothe anchor portion, the anchor portion comprising a portion distal ofthe curved puncture portion; and a delivery catheter comprising apuncture needle lumen, the puncture needle extending slidably throughthe puncture needle lumen, and a side outlet opening on a portion of thedelivery catheter configured to allow extension therethrough of at leasta portion of the curved puncture portion; one of distally or proximallytranslating the puncture needle relative to the delivery catheter torelease at least a portion of the curved puncture portion through theside outlet opening; and piercing tissue at a target tissue site to forman opening at the target tissue site using the puncture tip extendedthrough the side outlet opening.
 39. The method of claim 38, wherein thesystem further comprises a medical implant guide wire sheath configuredto slidably receive a medical implant guide wire, the medical implantguide wire sheath comprising a distal portion coupled to at least aportion of the curved puncture portion, and wherein the method furthercomprises advancing the medical implant guide wire within the medicalimplant guide wire sheath and through an opening associated with adistal end of the medical implant guide wire sheath into the openingformed at the target tissue site.
 40. The method of claim 38, whereinadvancing the puncture needle system into the vessel comprises advancingthe puncture needle system into a coronary sinus.
 41. The method ofclaim 38, wherein piercing tissue at the target tissue site comprisespiercing tissue on a left atrial wall.